Reported Jan 17, 2024 · Ongoing
QMS Tacrolimus Calibrators, Product code 10015573
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- QMS Tacrolimus Calibrators, Product code 10015573
- Lot codes and dates
No UDI Lot 74859619Expiry 11-May-2024
- Amount recalled
- 10 sales units US; 1 sales unit OUS
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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