Recall archive / FDA device enforcement
QMS Tacrolimus Calibrators, Product code 10015573 — FDA record Z-0712-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 21, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 10 sales units US; 1 sales unit OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0712-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | No UDI Lot 74859619, Expiry 11-May-2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 17, 2024
- Recall initiation date
- Nov 21, 2023
- Center classification date
- Jan 11, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.