Recall Z-0163-2016 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
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.
| Date | Sep 9, 2015 |
| Status | Terminated |
| Reason | Incorrect tubing. |
| 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 shou |
| Quantity | 65 units |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to France, Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |