Hyphen BioMed Recalls ZYMUTEST HIA MonoStrip IgG Assay Kits
Hyphen BioMed is recalling 12 ZYMUTEST HIA MonoStrip IgG 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: This is a labeling error regarding sample type usage, which falls under the rubric for minor labeling errors and voluntary precautionary recalls.
Plain-English summary
Hyphen BioMed is recalling 12 units of the ZYMUTEST HIA MonoStrip IgG assay kits (REF Number: RK041A; UDI: 03663537046803). The recall is due to an incorrect package insert that indicates the kits can be used with plasma, serum, and other biological fluids. The kits are intended to be used only with plasma.
The affected lots are F1701084P2 and F1701084P3. 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 further instructions. The kits are intended for in vitro diagnostic use to detect heparin-dependent antibodies of the IgG isotype in human plasma.
The recalled product
- Product
- ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
- Manufacturer
- Hyphen BioMed
- Hazard
- Affected units
- 12
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)
- Lot numbers: F1701084P2 and F1701084P3
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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