CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Zymutest HIA IgGAM recalled by Hyphen BioMed
Hyphen BioMed is recalling Zymutest HIA IgGAM, 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
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-1744-2018
- 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
- Reason category
- Potency & Assay
- 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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
OH, MD, NC, NY, NH, Canada, Sweden
Questions about this recall
Is Zymutest HIA IgGAM recalled?
Yes. Hyphen BioMed recalled Zymutest HIA IgGAM on 5 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1744-2018.
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, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hyphen BioMed
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Zymutest HIA MonoStrip IgG recalled by Hyphen BioMed | Hyphen BioMed | Potency & Assay | 5 states |
| Device | CLASS II | Zymutest HIA MonoStria qualitative screening assay intended recalled | Hyphen BioMed | Potency & Assay | 5 states |
| Device | CLASS II | Zymutest HIA MonoStrip IgGAM recalled by Hyphen BioMed | Hyphen BioMed | Potency & Assay | |
| Device | CLASS II | Zymutest HIA IgGAM recalled by Hyphen BioMed | Hyphen BioMed | Potency & Assay |
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