Recall Z-2423-2020— Tosoh Bioscience Inc

Name: FDA recall Z-2423-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-22

Class II · Terminated

Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2020-05-22, terminated 2024-08-29. FDA's recall record names no specific 510(k) clearance for this event. Product: AIA-900 Analyzer, Part no. 022930, UDI 04560189283992. Reason: The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results..

Recalling firm: Tosoh Bioscience Inc
Classification: Class II
Status: Terminated
Initiated: 2020-05-22
Terminated: 2024-08-29
Firm location: Grove City, OH, United States

Product description

AIA-900 Analyzer, Part no. 022930, UDI 04560189283992

Reason for recall

The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.