Recall Z-0712-2024
Ortho-Clinical Diagnostics, Inc. · initiated November 21, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
QMS Tacrolimus Calibrators, Product code 10015573
Codes / lots: No UDI Lot 74859619, Expiry 11-May-2024
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.
FDA-determined cause: Storage
Action taken
On 21 November 2023, all consignees who were shipped the VITROS QMS Tacrolimus Calibrators Lot 74859619 expiry date: 11-May-2024 from QuidelOrtho distribution center were notified of the issue and instructed to: -Discontinue using, render unusable, and discard your inventory of QMS Tacrolimus Calibrators, Lot 74859619, which was shipped to the laboratory from QuidelOrtho. -Post the notification by the laboratory s inventory storage area until a replacement lot of QMS Tacrolimus Calibrator has been received. -Forward the notification if the affected product was distributed outside their facility. If you have questions about this recall, please contact QuidelOrtho's Global Services Organization (formerly Ortho Care) at 1-800-421-3311.
Details
- Recall number
- Z-0712-2024
- Initiated
- November 21, 2023
- Posted by FDA
- January 11, 2024
- Product code
- JIT – Calibrator, Secondary
- Quantity
- 10 sales units US; 1 sales unit OUS
- Distribution
- Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc., Rochester, NY