VITROS Immunodiagnostic Products Anti-HBc IgM Controls…

Date

Nov. 24, 2021

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Ortho-Clinical Diagnostics, Inc.

Product

VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems

Reason

Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.

Distribution pattern

US (Domestic) distribution to states of: AZ, CA, CO, CT, FL, GA, LA, MA, MO, NJ, NY, OK, SC, SD, TX, UT, WA, WI, and WV. OUS (Foreign) distribution to Colombia.

Quantity

191 units

Codes and lots

Lot 1690 UDI 10758750001200

Recall started

Oct. 15, 2021

Device type

Single (Specified) Analyte Controls (Assayed And Unassayed)

Root cause (FDA)

Under Investigation by firm

What the company told customers

On October 15, 2021, the firm issued "Important Product Correction Notification" letters to affected customers. Customers were informed that up to 8 booklets in the affected lot contained the range of means information for VITROS Immunodiagnostic Products Anti-HBc Controls instead of the control values for VITROS Anti-HBc IgM. Customers were provided with a copy of the correct Controls Values booklet. Customers were asked to do the following: - Complete and return the included Confirmation of Receipt - Response Required customer response form by email to: ra-ocdus-confirmad@orthoclinicaldiagnostics.com or fax to: 1-888-557-3759 or 1-585-453-4110 - Retain the included Controls Values booklet to use in place of any recalled booklets - Forward the notification if the product was distributed outside your facility If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.

Recall number

Z-0247-2022

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

Source: FDA · Medical device enforcement report, recall number Z-0247-2022. The agency record governs; check it and the company before acting.