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U.S. Department of Health and Human Services

Class 2 Device Recall AIA900 Analyzer

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 Class 2 Device Recall AIA900 Analyzersee related information
Date Initiated by FirmSeptember 28, 2018
Create DateNovember 19, 2018
Recall Status1 Terminated 3 on July 08, 2020
Recall NumberZ-0485-2019
Recall Event ID 81219
Product Classification Fluorometer, for clinical use - Product Code KHO
ProductTosoh AIA-900 immunoassay Analyzer
Code Information 10313605 10503612 10634103
FEI Number 3005529799
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information ContactMs. Bernadette O'Connell
800-248-6764
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn September 28, 2018, the firm issued an Urgent Medical Device Recall letter to affected customers. Customers were informed of the software issue. The firm has released software version 2.51 (or later) which corrects the problem. Three analyzers were identified that do not have the most current software version and are at risk for the error: 10313605, 10503612, and 10634103. A field service engineer will be contacting customers with these units in their possession to schedule a service visit in order to upgrade those analyzers to the current version of the operating software. Immediate Actions to be taken by the Customer/User -Thoroughly review the content of this letter. -Complete and return the attached Acknowledgement Form. -File this notice with your laboratory records and forward this information to other supervisors or managers in your laboratory to ensure that they are aware of the potential issue. If you have obtained unexpected test results, delays in test result reporting, or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to contact Bernadette O'Connell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. She will be available to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in Commerce3
DistributionDistributed to accounts in GA and NY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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