SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
This recall has been terminated (originally issued November 30, 2004).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- October 25, 2004
- Posted
- November 30, 2004
- Terminated
- June 17, 2005
- Recall Number
- Z-0262-5
- Quantity
- 6,698
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
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.
Distribution
US and Canada
Lot / Code Info
Part number: 465101 Lot Numbers - Date of Mfg - Expiration Date M310237 - 10/29/2003 - 10/31/2004 M401010 - 01/15/2004 - 01/31/2005 M403026 - 03/05/2004 - 03/31/2005 M406041 - 06/10/2004 - 06/30/2005
Root Cause
Other
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.