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.
This recall has been terminated (originally issued September 9, 2015).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- September 9, 2015
- Terminated
- November 17, 2016
- Recall Number
- Z-0163-2016
- Quantity
- 65 units
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect tubing.
Distribution
Worldwide Distribution - US (nationwide) and Internationally to France, Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
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.