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

GEM Premier 4000 Laboratory Analyzer

FDA Recall Z-0778-2007 · Posted 2007-05-03

Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeCHL
Date Initiated2007-03-27
Date Terminated2012-05-23
Product Quantity210

Reason for Recall

Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result

Firm Action

Instrumentation Labs on 3/2707 notified Service Reps to perform on site mandatory upgrade. The foreign counterparts were advised by email on 3/21/07

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061974GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRITInstrumentation Laboratory CO · 2006-09-15

Official Source

View FDA Recall →

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

↑