FDANovember 21, 2023device

QMS Tacrolimus Calibrators, Product code 10015573

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in testing.

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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