Recall Z-0262-5 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Beckman Coulter Inc
SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
| Date | Nov 30, 2004 (initiated Oct 25, 2004) |
| Status | Terminated |
| Reason | Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential for carryover into the SYNCHRON Lipase (LIPA) assay, resulting ina substantial positive bias affecting Lipase (LIPA) results. |
| Root cause | Other |
| Action | The week of 10/25/2004, a product corrective action (PCA) letter was mailed vis U.S. mail to all customers shipped LIPA reagent for the 24 months preceding the discovery of the issue. Customers instructed to repeat any sample that produces a lipase value of > 170 U/L that cannot be confirmed by patient history. |
| Quantity | 6,698 |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970905 | SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT Beckman Instruments, Inc., Jun 4, 1997 |