Recall – Immunoassay Analyzer Software Issue

Company: Tosoh Bioscience Inc
Date of Enforcement Report: 11/19/2018
Class II:

PRODUCT
Tosoh AIA-900 immunoassay Analyzer

Recall Number: Z-0485-2019

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/MANUFACTURER
Tosoh Bioscience Inc, Grove City, OH on 9/28/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3

DISTRIBUTION
Distributed to accounts in GA and NY.

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

Corporate Office

15148 Springview St
Tampa, FL 33624
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+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.