Recall Z-0309-2018
Beckman Coulter Inc. · initiated November 6, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Codes / lots: Serial/Lot Numbers: 507114, 503299 and 508111
Reason for recall
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
FDA-determined cause: Device Design
Action taken
An Urgent Medical Device Recall letter, dated November 6, 2017, were sent to the affected customers via mail. The letter identifies the affected device, the reason for recall, impact, and actions to be taken. The firm states that customers may continue to operate their system normally. Customers are instructed to contact Technical Support if a device on the Access 2 instrument needs alignment. The alignment tool is only to be used by the Beckman Coulter service personnel and Beckman Coulter trained biomedical engineers. A Beckman Coulter service rep will contact customers to schedule a service visit. Customers are to share this information with their staff and retain a copy of the letter. Customers are to respond via one of the ways identified. Beckman Coulter should be contacted with any questions regarding the notice.
Details
- Recall number
- Z-0309-2018
- Initiated
- November 6, 2017
- Terminated
- November 4, 2019
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 3 units
- Distribution
- 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.
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0308-2018 Class III | Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for…Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when… | 11/06/2017Terminated |
| Z-0310-2018 Class III | UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic…Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when… | 11/06/2017Terminated |