Ortho-Clinical Diagnostics, Inc. has recalled 76 units of its VITROS Immunodiagnostic Products Vitamin B12 Range Verifier (Lot 1200) because Level 2 of the kit may fail to meet its required upper limit range during verification testing. While this issue does not affect the actual performance of the Vitamin B12 assay or past patient results, it can cause a delay in laboratory testing if staff must switch to an alternate method or lot to verify their equipment. This product is used by laboratory professionals to verify the calibration range of VITROS ECi, ECiQ, 3600, 5600, and XT 7600 systems.
The defect causes the product to fail its own internal quality checks, which can lead to a delay in patient test results while laboratory staff troubleshoot the verification failure or secure a different lot of the product.
Manufacturer notification and method switching
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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