Ortho-Clinical Diagnostics, Inc. Recall 93621
Description: QMS Tacrolimus Calibrators, Product code 10015573
Ortho-Clinical Diagnostics, Inc. Recall 93621 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0712-2024 |
| Event ID | 93621 |
| Event Description | QMS Tacrolimus Calibrators, Product code 10015573 |
| Product Type | Devices |
| Distribution | Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile. |
| Quantity | 10 sales units US; 1 sales unit OUS |
| Recall 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. |
| Device Classification | 20240117 |
| Device Code Info | No UDI Lot 74859619, Expiry 11-May-2024 |
| Center Classification Date | 20240111 |
| Recall Initiation Date | 20231121 |
| Recalling Firm | Ortho-Clinical Diagnostics, Inc. |
| Initial Notification | Letter |
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