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.
FDA Recall Z-2202-2015 · Posted 2015-07-22
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Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeJJE
Date Initiated2015-06-11
Date Terminated2016-02-09
Product Quantity5 units
Reason for Recall
The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
Firm Action
Abbott notified thier affected consignees via phone or visit on 5/29/15. A follow up Product Recall notification letter dated June 4, 2015 was sent to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use of the product, Abbott representative will be make all necessary arrangements for replacing your impacted instruments(s), follow your laboratory protocol regarding the need to review previously reported patient results and retain this notification for laboratory records. For questions contact Customer Service at 1-877-4ABBOTT.
Root Cause
Mixed-up of materials/components
Distribution Pattern
US Nationwide Distribution in the states of CA, AL, NY and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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