ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller Board Part #78
FDA device recall Z-0415-2007 · posted 2007-02-07 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- 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.
- Action taken
- Firm contacted consignees by telephone and fax with instructions to verify proper functioning of the Temperature Controller Board starting December 13, 2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 57 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, Taiwa
- Date initiated
- 2006-12-12
- Date posted
- 2007-02-07
- Date terminated
- 2007-09-24
- Location
- Irving, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT TESTOSTERONE (K983212) | Abbott Laboratories | 1998-11-18 |