FDAFDA · Food and drugs·Recall number Z-0712-2024
QMS Tacrolimus Calibrators, Product code 10015573
Published January 17, 2024 · Recall initiated: November 21, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Distributor
- Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
- Lot
- No UDI Lot 74859619, Expiry 11-May-2024
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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