FDA Medical Device Recalls (openFDA)
Hyphen BioMed: 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.
- Recall number
- Z-1063-2018
- Recalling firm
- Hyphen BioMed
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-11-09
- Posted
- 2018-03-15
- Terminated
- 2018-06-21
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 30
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Austria and France.
- Lot, serial or model codes
- UDI: 03663537046810. Lot Number: F1700416.
- 510(k) numbers
- ["K071255"]
- PMA numbers
- not on file
- Product code
- LCO
- Firm FEI
- 3004434070
- Firm city
- Eragny Neuville Sur Oise
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28