Hyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Risk
Hyphen BioMed is voluntarily recalling ZYMUTEST HIA IgGAM and MonoStrip assays because they may produce false positive results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is voluntary and precautionary, addressing a potential for false positive results without any reported injuries, illnesses, or fatalities in the source text.
Plain-English summary
Hyphen BioMed has initiated a voluntary recall for ZYMUTEST HIA IgGAM (Ref RK040D, Lot F1700415) and ZYMUTEST HIA MonoStrip IgGAM (Ref RK041D, Lot F1700416). These are qualitative screening assays used to detect heparin-dependent antibodies.
The recall is being conducted because the affected products may produce false positive results. The source text does not specify the number of units recalled, the specific distribution locations, or any reported injuries or illnesses associated with the use of these products.
Healthcare providers and laboratories should stop using the affected lots and contact Hyphen BioMed for further instructions or a replacement.
The recalled product
- Product
- ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
- Manufacturer
- Hyphen BioMed
- Hazard
- Affected units
- 94
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 03663537018770 Lot Number: F1700415
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Hyphen BioMed under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Hyphen BioMed
See all →- ModerateHyphen BioMed Recalls ZYMUTEST HIA MonoStria Assay Due to Labeling Error
FDA (Devices) · 2018-05-16
- ModerateHyphen BioMed Recalls ZYMUTEST HIA IgGAM Assay Kits Due to Incorrect Package Insert
FDA (Devices) · 2018-05-16
- ModerateHyphen BioMed Recalls ZYMUTEST HIA MonoStrip IgG Assay Kits
FDA (Devices) · 2018-05-16
- ModerateHyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Results
FDA (Devices) · 2018-03-21
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