FDA Recall
Terminated
Access 2 Immunoassay System
Recall: Z-0692-03
·
Initiated January 30, 2003
Recall
- Recall Number
- Z-0692-03
- Event Number
- 25601
- Firm
- Beckman Coulter Inc
- FEI Number
- 2050012
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 30, 2003
- Posted
- March 29, 2003
- Terminated
- June 1, 2004
- Address
- 200 South Kraemer Blvd W, 337, Brea, CA, 92822
Description
Access 2 Immunoassay System
Reason
False results from secondary pour off tubes
Action
Customers with the Access 2 instrument were informed of the recall issue by letter dated 1/30/2003. Those with the LXi 725 were informed by a letter dated 2/5/2003. The letters caution not to use certian Pour off tubes.
Distribution
Nationwide and Canada
Quantity
718