Recall Z-0416-2007 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.
| Date | Feb 7, 2007 (initiated Dec 12, 2006) |
| Status | Terminated |
| Reason | The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature control function of the board. Situation does not stop analyzer operation and does not generate an error condition alerting operator when condition occurs. |
| Root cause | Other |
| Action | Firm contacted consignees by telephone and fax with instructions to verify proper functioning of the Temperature Controller Board starting December 13, 2006. |
| Quantity | 648 units. |
| Distribution | Worldwide, including USA, Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Germany, Hong Kong, Jamaica, Japan, Korea, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad, Tobago, Uruguay, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983212 | ABBOTT ARCHITECT TESTOSTERONE Abbott Laboratories, Nov 18, 1998 |