—#35734

Product

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

FDA product code: CHI — Lipase-Esterase, Enzymatic, Photometric, Lipase
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K970905
Affected 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

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: US and Canada

Timeline

Recall initiated: 2004-10-25
Posted by FDA: 2004-11-30
Terminated: 2005-06-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35734. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.