Z-0262-5

SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465

Name: Z-0262-5 SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
Creator: Beckman Coulter Inc
Published: 2004-10-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-10-25 / Terminated

FDA source

Beckman Coulter Inc began a recall of SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465 on 2004-10-25. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0262-5
Status: Terminated
Initiated: 2004-10-25
Posted: 2004-11-30
Terminated: 2005-06-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
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.
FDA 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 in commerce: 6,698
Distribution: US and Canada
Product codes and lots: 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

Product code CHI

K970905Class ISynchron Cx Systems Lipase (Lipa) ReagentBeckman Instruments, Inc. / cleared 1997-06-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)