FDA Enforcement
Class II
Ongoing
QMS Tacrolimus Calibrators, Product code 10015573
Recall: Z-0712-2024
·
Reported January 17, 2024
Enforcement
- Recall Number
- Z-0712-2024
- Event ID
- 93621
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 17, 2024
- Initiation Date
- November 21, 2023
- Classification Date
- January 11, 2024
- Address
- 100 Indigo Creek Dr, Rochester, NY, 14626-5101, United States
Description
QMS Tacrolimus Calibrators, Product code 10015573
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 Info
No UDI Lot 74859619, Expiry 11-May-2024
Distribution
Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
Quantity
10 sales units US; 1 sales unit OUS