Z-0308-2018 Class III Terminated
FDA device recall Z-0308-2018 was initiated by Beckman Coulter Inc. on November 6, 2017 and is designated Class III. Reason for recall: Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment. The recall status is terminated (terminated November 4, 2019). Affected quantity: 227 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2018
- Initiation Date
- November 6, 2017
- Termination Date
- November 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 227 units
Product Description
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Reason for Recall
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Distribution Pattern
Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.
Code Information
Serial/Lot Numbers: 570005-570043, 570047-570049, 570051-570061, 570066-570071, 570073-570091, 570093-570123, 570125, 570126, 570128, 570131-570153, 570156-570203, 570205-570241, 570244-570248, 570250-570252 and 512684