# FDA recall Z-1284-2022

> **Microgenics Corporation** · Class II · device recall initiated 2022-01-20.

## Product

QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET    QMS TACROLIMUS CAL A 10015566-3  QMS TACROLIMUS CAL B 10015567-3  QMS TACROLIMUS CAL C 10015568-3  QMS TACROLIMUS CAL D 10015569-3  QMS TACROLIMUS CAL E 10015570-3  QMS TACROLIMUS CAL F 10015571-3

## Reason for recall

Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.

## Distribution

U.S.: AL, AZ, CA, DC, FL, IA, ID, IL, KY, LA, MA, NE, NJ, NM, OH, OK, PA, SC, TN, TX, and VA  O.U.S.: Bangladesh, Brazil, Canada, Germany, India, Malaysia, Mexico, South Korea, and Thailand

## Key facts

- **Recall number:** Z-1284-2022
- **Recalling firm:** Microgenics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-20
- **Report date:** 2022-07-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1284-2022

## Citation

> AI Analytics. FDA recall Z-1284-2022. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1284-2022. Source: US FDA. Licensed CC0.

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