FDA Device recall Z-0712-2024
QMS Tacrolimus Calibrators, Product code 10015573
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of QMS Tacrolimus Calibrators, Product code 10015573 by Ortho Clinical Diagnostics, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0712-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-21 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | FL, IL, IN, NJ, NM, TX |
Product
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.
Identifiers
| code_info | No UDI Lot 74859619, Expiry 11-May-2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0712-2024%22
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