Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or wh
FDA device recall Z-0028-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNN
- Quantity affected
- 21958
- Distribution
- United States, Canada and Germany
- Date initiated
- 2003-09-02
- Date posted
- 2003-10-15
- Date terminated
- 2003-12-10
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.