# FDA recall Z-1255-2021

> **R & D Systems, Inc.** · Class II · device recall initiated 2021-01-20.

## Product

Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)).  An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia.

## Reason for recall

R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits.

## Distribution

USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,

## Key facts

- **Recall number:** Z-1255-2021
- **Recalling firm:** R & D Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-20
- **Report date:** 2021-03-24
- **Termination date:** 2023-02-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1255-2021

## Citation

> AI Analytics. FDA recall Z-1255-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1255-2021. Source: US FDA. Licensed CC0.

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