Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1744-2018·Announced 2018-05-16

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.

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 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
Category: Medical Device — In Vitro Diagnostic Assay
Hazard: mis-labeling
incorrect-use-instructions
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

Distributed in 5 states:

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 →

Same manufacturer · Hyphen BioMed

See all →

Moderate
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FDA (Devices) · 2018-05-16
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Hyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Risk
FDA (Devices) · 2018-03-21
Moderate
Hyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Results
FDA (Devices) · 2018-03-21

Same hazard · mis labeling