COBAS TaqMan 48 Analyzers.
FDA Recall Z-1120-04 · Posted 2004-07-27
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Recalling FirmRoche Molecular Systems Inc
Recall StatusTerminated
Product CodeJJF
Date Initiated2004-05-24
Date Terminated2006-03-08
Product Quantity75
Reason for Recall
Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.
Firm Action
An Urgent Product Recall letter was sent to all customers with a COBAS TaqMan 96 and 48 analyzer on 5/24/2004 by overnight delivery with delivery confirmation. On May 25, 2004, All Roche Field Service Engineers were instructed to inspect the analyzers to confirm that the cables were properly seated.
Root Cause
Other
Distribution Pattern
Units are sold to hospitals, clinics, and clinical laboratories thoughout the US. There are 10 VA hospitals. There is one government agency, NIH, Bethesda, MD.
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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