Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic…

Date

July 20, 2022

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Ortho-Clinical Diagnostics, Inc.

Product

Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960

Reason

On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.

Quantity

20858

Codes and lots

UDI-DI :10758750034413. All expired, in-date and future released lots

Recall started

May 26, 2022

Device type

Reagent, Coronavirus Serological

Root cause (FDA)

Incorrect or no expiration date

What the company told customers

Ortho Clinical Diagnostics issued Important Correction Notification letter (CL2022-135) on May 26, 2022. Letter states reason for recall, health risk and action to take: When using VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack, do not store on-analyzer for longer than 6 weeks. " Until a lot update occurs, OAS for VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack will temporarily require manual monitoring and removal of reagent packs from analyzer no longer than 6 weeks after packs have been opened and loaded onto the analyzer. " Complete the enclosed Confirmation of Receipt form no later than June 9, 2022. " Post this notification by each VITROS ECi/ECiQ/3600/5600/XT 7600 System in your laboratory until further notice. " Please forward this notification if VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack was distributed outside of your facility. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311

Recall number

Z-1367-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1367-2022. The agency record governs; check it and the company before acting.