Recall Z-0712-2024 ยท JIT Calibrator, Secondary
Ortho-Clinical Diagnostics, Inc.
QMS Tacrolimus Calibrators, Product code 10015573
| Date | Jan 11, 2024 (initiated Nov 21, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Storage |
| Action | 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 faci |
| Quantity | 10 sales units US; 1 sales unit OUS |
| Distribution | Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS Microgenics Corp., Jul 11, 2013 |