Medical Device Recall: QMS Tacrolimus Calibrators, Product code 10015573
Ortho-Clinical Diagnostics, Inc. · November 21, 2023
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.
States Affected
FL, IL, IN, NJ, NM, TX
Quantity Affected
10 sales units US; 1 sales unit OUS
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0712-2024
Status: ongoing
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