FDA Medical Device Recalls (openFDA)
Hyphen BioMed: ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
- Recall number
- Z-1742-2018
- Recalling firm
- Hyphen BioMed
- Product
- ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
- Status
- Terminated
- Initiated
- 2018-02-05
- Posted
- not on file
- Terminated
- 2018-08-16
- Reason
- Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
- Root cause
- Packaging process control
- Action
- On March 6, 3018 Aniara Diagnostica began emailing Urgent Medical Device Recall notifications to affected customers. Customers are instructed to: Use the US Instructions for Use and Return the completed Acknowledgement Awareness Form. Customers with questions may contact Aniara Diagnostica via e-mail at Sandra@aniara.com or by phone at (866)783-3797 ext. 110.
- Quantity
- 12
- Distribution
- OH, MD, NC, NY, NH, Canada, Sweden
- Lot, serial or model codes
- Lot numbers: F1701084P2 and F1701084P3
- 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