QMS Tacrolimus Calibrators, Product code 10015573
FDA device recall Z-0712-2024 · posted 2024-01-11 · Open, Classified
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- 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.
- 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.
- Root cause
- Storage
- Status
- Open, Classified
- Product code
- JIT
- Quantity affected
- 10 sales units US; 1 sales unit OUS
- Distribution
- Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
- Date initiated
- 2023-11-21
- Date posted
- 2024-01-11
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS (K123343) | Microgenics Corp. | 2013-07-11 |