Hyphen BioMed Recalls ZYMUTEST HIA IgGAM Assay Kits Due to Incorrect Package Insert
Hyphen BioMed is recalling 281 units of the ZYMUTEST HIA IgGAM assay because the package insert incorrectly states the kits can be used with serum and other fluids, when they should only be used with plasma.
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: This is an FDA Class II recall involving a labeling error that could lead to incorrect test usage. It does not meet the criteria for High severity (no known pathogens or allergens) or Severe/Critical (no reported injuries or deaths). It fits the Moderate category for voluntary precautionary recalls or minor labeling errors affecting product use.
Plain-English summary
Hyphen BioMed is voluntarily recalling 281 units of the ZYMUTEST HIA IgGAM (REF Number: RK040D; UDI: 03663537018770). This product is a qualitative screening assay intended for the global detection of heparin-dependent antibodies (IgG, IgM, and IgA) in human plasma by clinical laboratories. The recall affects specific lot numbers: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, and F1701369P2.
The reason for the recall is that the package insert incorrectly indicates that the kits can be used with plasma, serum, and other biological fluids. The correct usage is limited to plasma only. Using the test with other fluids may lead to inaccurate results.
The affected products were distributed in Ohio, Maryland, North Carolina, New York, New Hampshire, Canada, and Sweden. No illnesses or injuries have been reported related to this recall.
The recalled product
- Product
- ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a 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.
- Manufacturer
- Hyphen BioMed
- Affected units
- 281
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 (6)
- Lot numbers: F1600568P1
- F1600568P2
- F1700415P1
- F1700415P2
- F1701369P1
- F1701369P2
Distribution
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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