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

COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R

FDA Recall Z-0475-06 · Posted 2006-02-04

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKJ
Date Initiated2005-12-15
Date Terminated2012-01-26
Product Quantity1134

Reason for Recall

There is a risk of sample misidentification when processing samples in the Manual aspiration mode.

Firm Action

A Product Corrective Action letter will be mailed the week of Dec 19, 2005 to all COUL TER@ LH700 Series System & COUL TER@ GEN.STM System customers instructing them of a rare risk of sample misidentification. (Letter will be sent by US mail)

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962988COULTER GEN-S SYSTEMCoulter Corp. · 1996-10-30

Official Source

View FDA Recall →

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

↑