Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0262-5 · Posted 2004-11-30

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeCHI
Date Initiated2004-10-25
Date Terminated2005-06-17
Product Quantity6,698

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.

Firm 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.

Root Cause

Other

Distribution Pattern

US and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970905SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENTBeckman Instruments, Inc. · 1997-06-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑