Recall database

Platelet Factor 4 Radioimmunoassay recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-2171-2026

Aniara Diagnostica LLC recalls ZYMUTEST HIA IgG

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Platelet Factor 4 Radioimmunoassay
Labeling Change Control

Aniara Diagnostica LLCOHMay 20, 2026

Class IIOngoingZ-1084-2026

Diagnostica Stago, Inc. recalls Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intende…

Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

Platelet Factor 4 Radioimmunoassay
Under Investigation by firm

Diagnostica Stago, Inc…NJJan 21, 2026