Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322.
FDA Recall Z-0649-05 · Posted 2005-03-23
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Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLCP
Date Initiated2005-02-15
Date Terminated2005-05-17
Product Quantity347,000 cassettes
Reason for Recall
The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
Firm Action
Recall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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