Z-2202-2015Class II

ARCHITECT c8000 System List Number 01G06-98

Name: Z-2202-2015 ARCHITECT c8000 System List Number 01G06-98
Creator: Abbott Laboratories
Published: 2015-06-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2015-06-11 / Terminated

FDA source

Abbott Laboratories began a recall of 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... on 2015-06-11. FDA classified it as Class II and gives the reason as "The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2202-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-11
Posted: 2015-07-22
Terminated: 2016-02-09
Recalling firm: Abbott Medical
Product: 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
FDA root cause: Mixed-up of materials/components
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.
Quantity in commerce: 5 units
Distribution: US Nationwide Distribution in the states of CA, AL, NY and WI.
Product codes and lots: Serial Numbers: C802239, C802312, C802260, C802447, C801911

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2202-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2202-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22

Product code JJE

K980367Class IIAeroset SystemAbbott Laboratories / cleared 1998-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)