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.
Reason for recall: 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. Distribution: Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile. Quantity: 10 sales units US; 1 sales unit OUS Lot/code info: No UDI Lot 74859619, Expiry 11-May-2024
Official record: FDA (Device enforcement) ↗
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