Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
This recall has been terminated (originally issued October 15, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- May 8, 2003
- Posted
- October 15, 2003
- Terminated
- December 9, 2003
- Recall Number
- Z-0012-04
- Quantity
- 478
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.
Distribution
United States
Lot / Code Info
All units with current software versions (v 06-06 and 07-01).
Root Cause
Other
Action Taken
Customers were notified by certified mail on or about May 12, 2003. Operators were given a workaround (assure R1 has the lower number of tests remaining before using the analyzer) until new software is supplied.
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