FDA Medical Device Recalls (openFDA)
Aniara Diagnostica LLC: ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
- Recall number
- Z-2347-2019
- Recalling firm
- Aniara Diagnostica LLC
- Product
- ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
- Status
- Terminated
- Initiated
- 2019-07-19
- Posted
- not on file
- Terminated
- 2021-06-11
- Reason
- Residual crystallization of the microplate and recurrent negative controls out of range.
- Root cause
- Under Investigation by firm
- Action
- The firm notified customers of the recall via Urgent Medical Device Correction emails dated July 26, 2019. Customers were informed of the recall and asked to destroy the affected kits in stock and indicate the quantity in the Awareness Acknowledgement Form, which was to be signed and returned to the local distributor. If you have any questions regarding this recall, please contact Aniara at (513) 360-6377, or CMurphy@aniara.com.
- Quantity
- 46
- Distribution
- Distribution to US states of NC, NH, NY, and OH, and Sweden.
- Lot, serial or model codes
- F1701571
- 510(k) numbers
- ["K071255"]
- PMA numbers
- not on file
- Product code
- LCO
- Firm FEI
- 3005017664
- Firm city
- West Chester
- Firm state
- OH
- Firm country
- not on file
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