Recall Z-2171-2026 ยท LCO Platelet Factor 4 Radioimmunoassay
Aniara Diagnostica LLC
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
| Date | May 12, 2026 (initiated Apr 1, 2026) |
| Status | Open, Classified |
| Reason | Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.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) |
| Quantity | 359 units |
| Distribution | US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A Hyphen Biomed, Sep 7, 2007 |