ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.

Recall Insight

This FDA Devices action (record #Z-2202-2015) was formally reported on July 29, 2015, with the manufacturer initiating the action on June 11, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Laboratories is listed as the recalling firm, operating out of Abbott Park, IL. Federal records indicate 5 units units are affected.

The documented reason for this recall is: The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of CA, AL, NY and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.