Hyphen BioMed Recalls ZYMUTEST HIA MonoStria Assay Due to Labeling Error
Hyphen BioMed is recalling ZYMUTEST HIA MonoStria kits because the package insert incorrectly lists serum and other fluids as valid sample types.
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 classified as FDA Class II, but the source text identifies the issue as an incorrect package insert (labeling error) without reporting any injuries or illnesses, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Hyphen BioMed is recalling 60 units of the ZYMUTEST HIA MonoStria qualitative screening assay. The product is intended for the detection of heparin-dependent antibodies in human plasma by clinical laboratories.
The recall was initiated because the package insert incorrectly indicates that the kits can be used with plasma, serum, and other biological fluids. The kits are only intended to be used with plasma. This labeling error could lead to improper use of the diagnostic device.
The affected lots are F1600568P1, F1701370P1, and F1701370P2. The products were distributed to clinical laboratories in Ohio, Maryland, North Carolina, New York, New Hampshire, Canada, and Sweden. Clinical laboratories should stop using the affected kits and contact Hyphen BioMed for instructions on return or disposal.
The recalled product
- 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
- Manufacturer
- Hyphen BioMed
- Hazard
- Affected units
- 60
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 (3)
- Lot numbers: F1600568P1
- F1701370P1
- F1701370P2
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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