# FDA recall Z-1743-2018

> **Hyphen BioMed** · Class II · device recall initiated 2018-02-05.

## Product

ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810

## Reason for recall

Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.

## Distribution

OH, MD, NC, NY, NH, Canada, Sweden

## Key facts

- **Recall number:** Z-1743-2018
- **Recalling firm:** Hyphen BioMed
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-05
- **Report date:** 2018-05-16
- **Termination date:** 2018-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Neuville Sur Oise, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1743-2018

## Citation

> AI Analytics. FDA recall Z-1743-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1743-2018. Source: US FDA. Licensed CC0.

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