—#171330

Product

VITROS ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

FDA product code: KHO — Fluorometer, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K962919
Affected lot / code info: Serial Numbers: 30005946, 30005947, 30005948, 30005960 through 30005975, 30005979 30005981 through 30005991 30005993, 30005994 30006000 through 30006005 UDI: 10758750000272

Why it was recalled

Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems

Root cause (FDA determination)

Software design

Action the firm took

Ortho Clinical Diagnostics (Ortho) issued an "URGENT PRODUCT CORRECTION NOTIFICATION" , a customer letter (Ref. CL2019-052) dated 21 February 2019 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to customers who were shipped affected VITROS Systems/or whose VITROS System has a luminometer parts replacement. The customers were notified of the issue and instructed to notify Ortho upon experiencing the issue described: -Avoid performing a shutdown/restart on your systems unless directed by an Ortho representative or prompted by condition code help text. -If you shutdown/restart and encounter any of the above Luminometer condition codes and are unable to process MicroWell assays, immediately contact the Ortho Care" Technical Solutions Center for service to your system. -Complete the enclosed Confirmation of Receipt form no later than March 1, 2019 by Fax: 1.888.557.3759 or 1.585.453.4110 or e-Mail Address: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM. -Please forward this notification if the product was distributed outside of your facility. Foreign affiliates were informed by email on 21 February 2019 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take. Questions contact Ortho Care" Technical Solutions Center at 1-800-421-3311.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.

Timeline

Recall initiated: 2019-02-20
Terminated: 2021-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171330. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.