Beckman Coulter Inc SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Beckman Coulter Inc is recalling SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465 due to Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026