CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
Zymutest HIA MonoStrip IgGAM recalled by Hyphen BioMed
Hyphen BioMed is recalling Zymutest HIA MonoStrip IgGAM. The recall was initiated on 9 Nov 2011 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-1063-2018
- FDA event ID
- 79269
- Recalling firm
- Hyphen BioMed, Neuville Sur Oise
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2011
- FDA classified
- 15 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Nov 2011 | Recall initiated by company | |
| 15 Mar 2018 | Classified by FDA | +2318 days |
| 21 Mar 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.
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 MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
Where it was distributed
Worldwide Distribution - US Distribution and to the countries of : Austria and France.
Questions about this recall
Why was it recalled?
A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.
Which lots are affected?
UDI: 03663537046810. Lot Number: F1700416.
Where was it sold?
Worldwide Distribution - US Distribution and to the countries of : Austria and France.
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
1 other product · FDA event 79269This product is part of a recall event; the main page for the event is Zymutest HIA IgGAM recalled by Hyphen BioMed.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Zymutest HIA IgGAM recalled by Hyphen BioMed | Hyphen BioMed | Potency & Assay |
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 | Packaging Defects | 5 states |
| Device | CLASS II | Zymutest HIA IgGAM recalled by Hyphen BioMed | Hyphen BioMed | Packaging Defects | 5 states |
| Device | CLASS II | Zymutest HIA MonoStria qualitative screening assay intended recalled | Hyphen BioMed | Packaging Defects | 5 states |
| Device | CLASS II | Zymutest HIA IgGAM recalled by Hyphen BioMed | Hyphen BioMed | Potency & Assay |
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