Recall Z-0028-04 ยท LNN
Roche Diagnostics Corp.
Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.
| Date | Oct 15, 2003 (initiated Sep 2, 2003) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 21958 |
| Distribution | United States, Canada and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.