Recipient: Tosoh Bioscience Inc.
Product: Immunoassay diagnostic packs and immunoassay systems
Date: 3/22/05
Specifically, our inspections revealed that on or about March 27, 2003, your firm was notified by Tosoh Corporation, Tokyo, Japan that a new software revision, version 3.12, was being released to correct washing errors in the analyzer that resulted in discrepant troponin results. FDA has classified your software upgrade to your customer’s analyzers as a Class I recall. A Class I designation indicates a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death (21 CFR 7.41). FDA regulations require manufacturers and importers to promptly report to FDA any correction or removal of a device if the correction or removal was initiated to reduce a risk to health. See 2I CFR 806.10(a)(1). Your firm’s action described above meets the definition of a “correction” in 21 CFR 806.2(d). In addition, FDA has found that the removal was initiated to reduce a risk to health. You therefore failed to report the product removal, as required by 21 CFR 806. 10(a)(1), until the issue was raised by our investigator.
Issuer: San Francisco District Office
