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
This recall has been terminated (originally issued October 15, 2021).
- Company
- Ortho-Clinical Diagnostics, Inc.
- Recall Initiated
- October 15, 2021
- Terminated
- December 18, 2023
- Recall Number
- Z-0247-2022
- Quantity
- 191 units
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
Reason for Recall
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
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.
Lot / Code Info
Lot 1690 UDI 10758750001200
Root Cause
Under Investigation by firm
Action Taken
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.