medical Class II Updated 2018-11-28

Tosoh Bioscience Inc recalls Tosoh AIA-900 immunoassay Analyzer

Recalled Product

Tosoh AIA-900 immunoassay Analyzer


Hazard / Issue

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.

Issued by

FDA

Affected States: GA, NY
Lot/Code Info: 10313605 10503612 10634103
View official government recall

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