VITROS Immunodiagnostic Anti-HBc Controls Recalled Due to Incorrect Booklet Information
Ortho-Clinical Diagnostics recalled 191 units of VITROS Anti-HBc IgM Controls (Lot 1690) because the Controls Values booklet contained incorrect product information. Although patient test result accuracy is not affected, there is potential for delayed quality control troubleshooting.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving a documentation and labeling error in a control materials booklet. No illnesses or injuries have been reported, and the source explicitly states that the accuracy of patient test results is not affected. The hazard is limited to potential delays in quality control troubleshooting.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 191 units of VITROS Immunodiagnostic Products Anti-HBc IgM Controls (Product Code 6801427, Lot 1690). These control materials are used to monitor the performance of VITROS immunodiagnostic laboratory systems.
The recall was issued because the Controls Values booklet included with some units contained information for an incorrect product. This labeling error could cause delays when laboratory operators troubleshoot quality control results, though the accuracy of patient test results themselves is not affected.
The affected controls were distributed to 19 U.S. states (Arizona, California, Colorado, Connecticut, Florida, Georgia, Louisiana, Massachusetts, Missouri, New Jersey, New York, Oklahoma, South Carolina, South Dakota, Texas, Utah, Washington, Wisconsin, and West Virginia) and to Colombia.
If you have received affected units, contact Ortho-Clinical Diagnostics for the correct product information.
The recalled product
- 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
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 1690 UDI 10758750001200
Distribution
Distributed in 19 states:
- AZ
- CA
- CO
- CT
- FL
- GA
- LA
- MA
- MO
- NJ
- NY
- OK
- SC
- SD
- TX
- UT
- WA
- WI
- WV
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