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Recall Observatory FDA recall evidence

Device product

QMS Tacrolimus Calibrators, Product code 10015573

Z-0712-2024

November 21, 2023

Class II

Product summary

Firm
Ortho-Clinical Diagnostics, Inc.
Event
Event 93621
Status
Ongoing
Classification
Class II
Quantity
10 sales units US; 1 sales unit OUS
Official record key
device-enforcement:Z-0712-2024

Official wording

Reason: 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.

Code information: No UDI Lot 74859619, Expiry 11-May-2024

Distribution pattern: Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.