ZYMUTEST HIA MonoStrip IgGAM recallZ-1063-2018 · Hyphen BioMed · initiated Nov 9, 2011
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hyphen BioMed or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Other
What the company is doing
The manufacturer, HYPHEN BioMed, initiated a voluntary recall of the two lots via email. Distributors and end users are being notified and instructed to: 1) acknowledge receipt and understanding of notification, and 2) destroy affected products remaining in stock. For further questions, please call (513) 770-1993.
Recall details
- Recall number
- Z-1063-2018
- Status
- Terminated
- Initiated by the company
- Nov 9, 2011
- Posted by the FDA
- Mar 15, 2018
- Recalling firm
- Hyphen BioMed
- Quantity
- 30
- Product code
- LCO
- FDA submissions
- K071255
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Austria and France.
Product description
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.
Code information (models, lots, serial numbers)
UDI: 03663537046810. Lot Number: F1700416.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ZYMUTEST HIA MonoStrip IgGAM RK041DHyphen Biomed · Platelet Factor 4 Radioimmunoassay1 recall0 reports
Other devices under the same FDA submission
2 devices cleared under K071255 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ZYMUTEST HIA IgG RK040AHyphen Biomed · Platelet Factor 4 Radioimmunoassay1 recall0 reports
- ZYMUTEST HIA IgGAM RK040DHyphen Biomed · Platelet Factor 4 Radioimmunoassay1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 79269).
- Z-1062-2018 · TerminatedZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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