Recall Z-0485-2019— Tosoh Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-09-28, terminated 2020-07-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Tosoh AIA-900 immunoassay Analyzer. Reason: A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result..
- Recalling firm
- Tosoh Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-28
- Terminated
- 2020-07-08
- Firm location
- Grove City, OH, United States
Product description
Tosoh AIA-900 immunoassay Analyzer
Reason for recall
A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.
Data sourced from openFDA. This site is unofficial and independent of the FDA.