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

ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.

FDA Recall Z-0008-06 · Posted 2005-10-06

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2005-02-28
Date Terminated2005-11-03
Product Quantity1,107 units worldwide

Reason for Recall

Device has incorrect notation associated with therapeutic drug monitoring assays.

Firm Action

Firm sent device correction letters to consignees on 2/28/2005.

Root Cause

Other

Distribution Pattern

California, Louisiana, Massachusetts, North Carolina, Missouri, Oklahoma, Texas, Illinois, Minnesota, South Dakota, North Dakota and Arizona. Foreign countries: Mexico, Columbia, Chile, Canada, Germany, Singapore, China, Australia, and New Zealand

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.

↑