Z-0163-2016Class II

ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The...

Name: Z-0163-2016 ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The...
Creator: Abbott Laboratories, Inc
Published: 2015-09-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2015-09-09 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated... on 2015-09-09. FDA classified it as Class II and gives the reason as "Incorrect tubing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0163-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-09
Posted: 2015-10-26
Terminated: 2016-11-17
Recalling firm: Abbott Medical
Product: ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Incorrect tubing.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Abbott Laboratories executed a Technical Service Bulletin on August 14, 2015.. The firm sent out a Product Correction notice on September 9, 2015 to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed that an Abbott representative will make all necessary arrangements for replacing tubing on the impacted instruments. Customers were asked to retain a copy of the notice for their records. Customers with questions were instructed to contact Customer Service at 1-877-4ABBOTT. Customers outside the US should contact their local area Customer Service. For questions regarding this recall call 877-422-2688.
Quantity in commerce: 65 units
Distribution: Worldwide Distribution - US (nationwide) and Internationally to France, Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan
Product codes and lots: ISR03967, ISR04737, ISR01461, ISR01998, ISR01964, ISR02446, ISR02751, ISR02781, ISR05266, ISR04520, ISR01460, ISR01442, ISR01988, ISR03034, ISR01194, ISR01583, ISR01955, ISR02437, ISR03144, ISR03352, ISR04369, ISR02360, ISR02361, ISR02842, ISR03495, ISR03756, ISR04244, ISR04420, ISR05155, ISR05240, ISR05242, ISR05433, ISR05671, ISR05883, ISR05946, ISR06050, ISR06054, ISR06837, ISR06864, ISR01696, ISR02073, ISR02264, ISR02269, ISR02999, ISR03668, ISR03901, ISR04053, ISR04165, ISR04388, ISR04586, ISR04619, ISR04770, ISR04773, ISR04775, ISR04801, ISR04996, ISR05202, ISR05662, ISR05732, ISR05751, ISR06406, ISR06592, ISR07108, ISR07240, ISR07741

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0163-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0163-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-26

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)