Analyzer, with software version 3.02, produced occurrence of false positive and false negative. The FDA first learned of this problem during an inspection of the firm during August – September 2004.
Product: Tosoh Bioscience AIA-600 II Enzyme Immunoassay Analyzer, software version 3.02.
Use: This laboratory analyzer is used by laboratory professionals to measure thyroid hormones, cardiac markers including troponin, tumor markers, as well as several other assays.
Recalling Firm: Tosoh Bioscience, Inc.
347 Oyster Pont Blvd, Suite 201
South San Francisco, CA 94080
Reason for Recall: This analyzer, with software version 3.02, produced occurrence of false positive and false negative results which could lead to aggravation of the patientâ€™s clinical condition, delay in treatment and potentially death.
Patients with small myocardial infarctions are particularly at risk of being negatively affected by false troponin test results
Patients with small myocardial infarctions are particularly at risk of being negatively affected by false troponin test results. The firm developed a software upgrade but the corrective action was not adequate because the firm did not contact users alerting them of the problem nor did the firm describe how the problems could be corrected.
FDA Comment: Clinical laboratories are advised to insure they have the latest software installed. The manufacturer should provide the FDA with assurance of validation of its corrective action, including validation of the corrected software, version 3.12. FDA considers that the probability of life threatening consequences is likely to occur by use of an uncorrected analyzer. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.