Abbott Laboratories, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
All serial numbers, List number 1G06-01
Products Sold
All serial numbers, List number 1G06-01
Abbott Laboratories, Inc is recalling ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemis due to Software deficiency causing potential shift in absorbance readings for test results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software deficiency causing potential shift in absorbance readings for test results.
Recommended Action
Per FDA guidance
Firm sent device correction letter to consignees on 9/14/2005.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026