FDA Device

COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345

Hazard

After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.

What You Should Do

Remedy

An urgent product removal bulletin dated 2/14/03 was sent to each affected customer advising them to discontinue use of this lot, to discard any product on hand, and to contact Roche for replacement.

Products

COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345
Brand
Roche Diagnostics Corp.
UPC
lot 639106

Units Affected

1905