CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Zymutest HIA MonoStria qualitative screening assay intended recalled

Hyphen BioMed is recalling Zymutest HIA MonoStria qualitative screening assay intended for the global detection of, distributed in Maryland, North Carolina, New Hampshire, New York, Ohio. The recall was initiated on 5 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: F1600568P1, F1701370P1, F1701370P2

Quantity recalled60

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1743-2018
FDA event ID: 79797
Recalling firm: Hyphen BioMed, Neuville Sur Oise, N/A
Classification: Class II
Status: Terminated
Recall initiated: 5 Feb 2018
FDA classified: 8 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Test Kits & Diagnostics

Timeline

5 Feb 2018	Recall initiated by company
8 May 2018	Classified by FDA	+92 days
16 May 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

OH, MD, NC, NY, NH, Canada, Sweden

Maryland North Carolina New Hampshire New York Ohio

Questions about this recall

Why was it recalled?

Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.

Which lots are affected?

Lot numbers: F1600568P1, F1701370P1, F1701370P2

Where was it sold?

OH, MD, NC, NY, NH, Canada, Sweden

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 79797

Reported	Class	Recall	Company	Reason	Where
16 May 2018	CLASS II	Zymutest HIA IgGAM recalled by Hyphen BioMed	Hyphen BioMed	Packaging Defects	5 states
16 May 2018	CLASS II	Zymutest HIA MonoStrip IgG recalled by Hyphen BioMed	Hyphen BioMed	Packaging Defects	5 states

More recalls from Hyphen BioMed

All 5

Reported	Class	Recall	Company	Reason	Where
16 May 2018Device	CLASS II	Zymutest HIA MonoStrip IgG recalled by Hyphen BioMed	Hyphen BioMed	Packaging Defects	5 states
16 May 2018Device	CLASS II	Zymutest HIA IgGAM recalled by Hyphen BioMed	Hyphen BioMed	Packaging Defects	5 states
21 Mar 2018Device	CLASS II	Zymutest HIA MonoStrip IgGAM recalled by Hyphen BioMed	Hyphen BioMed	Potency & Assay
21 Mar 2018Device	CLASS II	Zymutest HIA IgGAM recalled by Hyphen BioMed	Hyphen BioMed	Potency & Assay

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