FDA Medical Device Recalls (openFDA)
Aniara Diagnostica LLC: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
- Recall number
- Z-2171-2026
- Recalling firm
- Aniara Diagnostica LLC
- Product
- ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
- Status
- Open, Classified
- Initiated
- 2026-04-01
- Posted
- 2026-05-12
- Terminated
- not on file
- Reason
- Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
- Root cause
- Labeling Change Control
- Action
- A Field Corrective Action notification letter dated 3/30/26 was sent to customers. Actions implemented by HYPHEN BioMed: -Confirmation of the existence of a flyer discrepancy affecting 95 kits from lot FD1265. - Request for quarantine of the affected kits in US agent warehouse. -Coordination with US agent for notification of the impacted end users. -investigation to define the root cause and to establish corrective and preventive actions. Actions to be implemented by the end user: 1. Check the TAV flyer included in their kit. - If the flyer matches the correct version (dated 18 October 2024) - No action is required. - If the flyer corresponds to the incorrect version (dated I October 2024) - proceed to step 2 2. Destroy the incorrect TAV flyer. The outdated flyer included in the kit must be immediately removed and destroyed, as well as any paper or electronic copy that could have been done in end-user facility, to prevent further use. 3. Replace the incorrect flyer with the corrected version. Use the corrected TAV flyer provided with this notice for all future testing 4. Return the completed and signed form to your local distributor before April 15th, 2026. For any question or information regarding this notification, please contact vigilance team, by email at VigilanceHBM@hyphen-biomed.com.
- Quantity
- 359 units
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
- Lot, serial or model codes
- UDI-DI: 03663537018763; Lot Number: FD1265
- 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