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

Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000

FDA Recall Z-1127-2007 · Posted 2007-08-07

Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeGKP
Date Initiated2007-06-19
Date Terminated2012-05-23
Product Quantity94

Reason for Recall

ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.

Firm Action

Instrumentation Laboratory notiifed the distributor Beckman Coulter on 6/19/2007. Beckman Coulter notified their customers and provided a copy with the Instructions for Recovery Procedure on how to avoid contamination from probe leaks.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063679ACL TOPInstrumentation Laboratory CO · 2007-01-12

Official Source

View FDA Recall →

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

↑