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Terminated

ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

FDA Recall Z-0010-06 · Posted 2005-10-06

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2005-09-14
Date Terminated2007-09-25
Product Quantity1,107 units

Reason for Recall

Software deficiency causing potential shift in absorbance readings for test results.

Firm Action

Firm sent device correction letter to consignees on 9/14/2005.

Root Cause

Other

Distribution Pattern

Nationwide and 21 foreign countries. Foreign countries: Mexico, Guatemala, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Puerto Rico, Jamaica, San Salvador, Canada, Germany, Singapore, China, Thailand, Australia, New Zealand, Panama, and Grand Cayman

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980367AEROSET SYSTEMAbbott Laboratories · 1998-04-01

Official Source

View FDA Recall →

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

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