Hyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Results
Hyphen BioMed is voluntarily recalling ZYMUTEST HIA assays because they may produce false positive results. The recall affects specific lots distributed in the US, Austria, and France.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a voluntary precautionary measure for a diagnostic device that may produce false positive results, which fits the criteria for a moderate severity recall involving low-risk contamination or labeling errors without reported injuries.
Plain-English summary
Hyphen BioMed has initiated a voluntary recall for ZYMUTEST HIA lgGAM (Ref RK040D, Lot F1700415) and ZYMUTEST HIA MonoStrip lgGAM (Ref RK041D, Lot F1700416). These products are qualitative screening assays used for the detection of heparin-dependent antibodies.
The recall was initiated because the affected products may produce false positive results. The recall covers 30 units of the MonoStrip model. Distribution was worldwide, with specific US distribution and sales to Austria and France.
Consumers and healthcare providers should stop using the affected lots and contact Hyphen BioMed for further instructions or a replacement.
The recalled product
- Product
- ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
- Manufacturer
- Hyphen BioMed
- Hazard
- Affected units
- 30
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: 03663537046810. Lot Number: F1700416.
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
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See all →- ModerateHyphen BioMed Recalls ZYMUTEST HIA MonoStria Assay Due to Labeling Error
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