COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345
This recall has been terminated (originally issued March 21, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- February 13, 2003
- Posted
- March 21, 2003
- Terminated
- March 20, 2003
- Recall Number
- Z-0667-03
- Quantity
- 1905
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.
Distribution
United States
Lot / Code Info
lot 639106
Root Cause
Other
Action Taken
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.
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