SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
FDA device recall Z-0262-5 · posted 2004-11-30 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHI
- Quantity affected
- 6,698
- Distribution
- US and Canada
- Date initiated
- 2004-10-25
- Date posted
- 2004-11-30
- Date terminated
- 2005-06-17
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT (K970905) | Beckman Instruments, Inc. | 1997-06-04 |