QMS Tacrolimus Calibrators — Class II medical device recall Z-0712-2024
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2024-01-17, distributed in FL, IL, IN, NJ, NM, TX. Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 20
| Recall number | Z-0712-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2023-11-21 |
| Classified | 2024-01-11 |
| Reported by FDA | 2024-01-17 |
| Distributed | FL, IL, IN, NJ, NM, TX |
| Countries outside the US | CL |
| Lot numbers | 74859619 |
| Expiration dates | 2024-05-11 |
Product
QMS Tacrolimus Calibrators, Product code 10015573
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0712-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.