Aniara Diagnostica Llc: Platelet Factor 4 Radioimmunoassay
Recall Summary Aniara Diagnostica LLC is recalling ZYMUTEST HIA IgG diagnostic test kits from lot FD1265 because they were packaged with an outdated instruction flyer containing incorrect positive control values. The kits were distributed nationwide across multiple states. This is a Class II recall, meaning the product could cause incorrect test results but is unlikely to cause serious health problems.
- Recalling firm
- Aniara Diagnostica LLC
- Product
- ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
- 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- Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-01
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b86e0a10-b841-445b-b9b5-7a6ac9f88bd3