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Recall Observatory FDA recall evidence

Device product

Tosoh AIA-900 immunoassay Analyzer

Z-0485-2019

September 28, 2018

Class II

Product summary

Firm
Tosoh Bioscience Inc
Event
Event 81219
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0485-2019

Official wording

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.

Code information: 10313605 10503612 10634103

Distribution pattern: Distributed to accounts in GA and NY.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue