# FDA recall Z-0712-2024

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2023-11-21.

## 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.

## Distribution

Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.

## Key facts

- **Recall number:** Z-0712-2024
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-21
- **Report date:** 2024-01-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0712-2024

## Citation

> AI Analytics. FDA recall Z-0712-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0712-2024. Source: US FDA. Licensed CC0.

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