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.
FDA Recall Z-0163-2016 · Posted None
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Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2015-09-09
Date Terminated2016-11-17
Product Quantity65 units
Reason for Recall
Incorrect tubing.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to France, Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan
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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