Z-0712-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2024
- Initiation Date
- November 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 sales units US; 1 sales unit OUS
Product Description
QMS Tacrolimus Calibrators, Product code 10015573
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 Pattern
Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
Code Information
No UDI Lot 74859619, Expiry 11-May-2024