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QuidelOrtho Initiates Class III Device Recall for B12 Test Component

NEW YORK – QuidelOrtho has initiated a Class III device recall for a component associated with its Vitros B12 immunodiagnostic assay, according to the US Food and Drug Administration.

In a document posted by the agency on Tuesday, the recall was initiated on May 8. Results generated by lot number 1200 of the Vitros Vitamin B12 Range Verifier may cause range verification failure, according to the document, adding the issue is detectable by the user when the product fails to meet the required range during processing.

Class III recalls are the least serious of the FDA's three types of recalls and apply to minor product defects and errors that are not likely to harm individuals.

The FDA said there is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification, including use of an alternate lot. However, since the issue only affects the upper limit range verification, there is no impact to Vitros Immunodiagnostic Products Vitamin B12 assay performance.

Were the assay to not perform as expected, the failure would be detectable by quality control, the FDA said, adding that past patient sample results are unaffected, and no review of reported results is required.

The QuidelOrtho Vitros system was subject to a recall last month for a quality control component of a Vitros test to measure thyroid function.