FDA Device Recalls

Recalls / Firms / Remel, Inc

Remel, Inc

112 FDA device recalls on record.

DateClassProductReason
2026-03-24Yeastone Broth, 11ML, 10/BOX YY3462
2026-02-05Campy CVA Medium 100/PK, R01272
2025-11-121. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
2025-07-11Strep Selective II Agar, Product Number R01859
2025-07-11Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
2025-07-11Blood/EMB, Levine 100/PK, Product Number R02041
2025-07-11Blood/MacConkey Biplate 100/PK, Product Number R02049
2025-05-01Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blo
2025-02-13remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
2025-02-13remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
2025-02-12Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optio
2024-09-20remel BactiDrop Acridine Orange, REF 21502, 50 per package.
2023-08-14remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinica
2023-05-31Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (
2022-10-20Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
2022-10-20Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
2022-10-20Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
2022-10-20Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
2022-10-20Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
2022-10-20Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
2022-10-20Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
2022-10-20Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
2022-10-20Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
2022-01-10Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
2021-06-18ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
2021-04-22Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: u
2021-03-10Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a s
2021-03-10Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a so
2020-12-10Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
2019-04-17Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use in qualitative procedures
2019-04-17Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedure
2019-04-17Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for use in qualitative procedure
2019-04-17Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures
2019-04-17Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedure
2019-04-17Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedur
2019-04-17Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedur
2019-04-17Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures a
2019-04-17Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures a
2019-04-17Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures
2019-04-17Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures a
2019-04-17Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as
2019-04-17Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedu
2019-04-17Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for use in qualitative proced
2019-01-04SWIN 2017 database, Model YSW4000
2018-08-13remel THIOGLYCOLLATE MEDIUM, REF 05152
2018-08-13remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c)
2018-08-13remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF
2017-12-08Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitabl
2017-11-02CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
2017-03-24Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Prod
2017-02-09Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
2016-03-24Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic
2015-11-06Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of
2015-06-30PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap.
2015-06-30PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for id
2015-05-19VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for
2015-05-19VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for
2015-05-04Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per c
2015-02-05Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsi
2014-11-13Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement
2014-10-29Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain fo
2014-10-23Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contai
2014-10-23Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of com
2014-10-17Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth suppl
2014-06-11Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, I
2014-03-17Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a varie
2014-03-17Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of co
2014-02-18Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on
2014-01-24Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyoph
2013-11-21Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in p
2013-05-02Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per bo
2013-05-02Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contai
2013-04-09Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges o
2013-04-09Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges
2013-04-09Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges
2013-04-09Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of
2013-04-04remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeas
2013-03-25Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cart
2013-02-19Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains
2012-11-21Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartrid
2012-10-10The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE
2012-08-21Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, o
2012-08-21Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per car
2012-08-20Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 246
2012-08-20Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 246
2011-05-11Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per package. The
2011-04-21remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the labe
2011-04-21remel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. The firm name on the labe
2010-01-18remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pou
2009-12-21Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hamps
2009-12-08remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the
2009-10-28ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with
2009-07-20Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road, Basingstoke
2009-07-20Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500
2009-05-07Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. Th
2009-05-06Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is R
2008-11-18Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests),
2008-10-07Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for th
2008-08-11Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use. A r
2007-10-23Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in
2007-10-23Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in
2007-02-21Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on t
2006-02-14Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., B
2004-09-27Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The fi
2003-12-09ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496.
2003-11-03Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the lab
2003-10-02Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and
2002-12-05REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 c
2002-11-21ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.
2002-07-18ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 247409
2002-07-15ProSpecT Campylobacter Microplate Assay. Catalog #2476096.
2002-05-09ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.