AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Reported: July 1, 2020 Initiated: May 22, 2020 #Z-2423-2020
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.
Details
- Recalling Firm
- Tosoh Bioscience Inc
- Units Affected
- 529
- Distribution
- Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay.
- Location
- Grove City, OH
Frequently Asked Questions
What product was recalled? ▼
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992. Recalled by Tosoh Bioscience Inc. Units affected: 529.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2020. Severity: Moderate. Recall number: Z-2423-2020.
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