Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.
This recall has been terminated (originally issued October 15, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- September 2, 2003
- Posted
- October 15, 2003
- Terminated
- December 10, 2003
- Recall Number
- Z-0028-04
- Quantity
- 21958
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.
Distribution
United States, Canada and Germany
Lot / Code Info
All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.
Root Cause
Other
Action Taken
Recall letters were sent to U.S. customers on 9/2/03 instructing them not to run lactate with these analyzers. An update notification letter was sent on or about 9/18/03 telling customers to discontinue use of the product for manual lactate determinations.
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