ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.
FDA Recall Z-0415-2007 · Posted 2007-02-07
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Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2006-12-12
Date Terminated2007-09-24
Product Quantity57 units.
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.
Firm Action
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
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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