—#173424

Product

ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K060964
Affected lot / code info: a. List Number 8K2802 - Lot Number (Expiration Date) UDI: 44K79318 (23JUL2019) (01)00380740017460(17)190723(10)44K79318, 44K80818 (05SEP2019) (01)00380740017460(17)190905(10)44K80818, 44K82118 (09OCT2019) (01)00380740017460(17)191009(10)44K82118, 44K82618 (15NOV2019) (01)00380740017460(17)191115(10)44K82618, 44K85119 (22JAN2020) (01)00380740017460(17)200122(10)44K85119; b. List Number 8K2803 - Lot Number (Expiration Date) UDI: 44K79418 (23Jul2019) (01)00380740145255(17)190723(10)44K79418, 44K81018 (5Sep2019) (01)00380740145255(17)190905(10)44K81018, 44K82018 (9Oct2019) (01)00380740145255(17)191009(10)44K82018, 44K85219 (22Jan2020) (01)00380740145255(17)200122(10)44K85219; c. List Number 8K2809, Lot Number 44K84119, Expiration Date 17Dec2019, No UDI

Why it was recalled

Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Abbott Laboratories notified customers on about 05/24/2019 via "Product Recall" letter. If customers did not have an alternate calibrator and/or control lots available in inventory and a valid calibration calibration curve has been generated, then customers should immediately order replacement calibrator and/or control lots. Valid calibration curves generated with the affected calibrator lots can still be used as long as controls not listed on the customer notification letter remain within range. The control lots listed in the letter CANNOT be used to validate the calibration curves. Destroy any inventory of the affected lots according to your laboratory procedures. If customers have alternate calibrator and/or control lots available in inventory, then discontinue use of the impacted lots immediately and switch to the alternate calibrator and/or control lots. Destroy any remaining inventory of the calibrator and/or control lots according to your laboratory practices. For customers who have, and are currently using, specified lots (outlined in the customer letter), expiration dates should be adjusted as instructed. Reference customer letter. The ARCHITECT software will continue to track to original dating as assigned during the manufacture of these lots. Manual tracking of the newly assigned expiration dates will have to be performed for each individual instrument, kit, and laboratory. Obtain replacement calibrator and/or controls prior to adjusted expiration to maintain testing. All future calibrator and control lots will have shortened expiration dating and will require adjustments to laboratory inventory and order management practices. Please contact your local Abbott representative for assistance and advice on optimization of workflow in your laboratory. Customers were also instructed to complete and return the Customer Reply form, notify customers if the affected products were further distributed, and retain a copy of the letter for lab

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Bldg Ap8b, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed worldwide to ALGERIA, ANDORRA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVI, BRUNEI, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CROATIA, CURACAO, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GREENLAND, HONDURAS, HUNGARY, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, KYRGYZSTAN, LEBANON, LITHUANIA, LUXEMBOURG, MACEDONIA, MALDIVES, MALI, MAURITANIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TANZANIA, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UNITED KINGDOM, VIETNAM, ZIMBABWE.

Timeline

Recall initiated: 2019-05-24
Terminated: 2021-04-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173424. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.