FDA Device

COBAS TaqMan Analyzer

Hazard

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.

What You Should Do

Remedy

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.

Products

COBAS TaqMan Analyzer
Brand
Roche Molecular Systems Inc
UPC
COBAS TaqMan Analyzer Serial Numbers: 381046; 381053; 391159; 391166; 391181; 371036; 391130; 391095; 381052; 391191; 391096; 381044; 391131; 381050; 381054; 391180; 381045; 391177; 391189; 381047; 381051; 381055; 391182; 391157; 391148; 391135; 391143; 391141; 391138; 391175; 391144; 391161; 391150; 391156.

Units Affected

34