Ortho-Clinical Diagnostics, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
Lot 1690 UDI 10758750001200
Products Sold
Lot 1690 UDI 10758750001200
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring due to Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet con. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, CT, FL, GA, LA, MA, MO, NJ, NY, OK, SC, SD, TX, UT, WA, WV, WI
Page updated: Jan 10, 2026