Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
FDA Recall Z-0023-2007 · Posted 2006-10-12
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Recalling FirmAbbott Diagnostic International, Ltd.
Recall StatusTerminated
Product CodeJIS
Date Initiated2006-09-07
Date Terminated2011-09-09
Product Quantity797
Reason for Recall
Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
Firm Action
The Device Recall Letter dated September 07, 2006, and Customer Reply Form was sent via Federal Express Priority mail to all customers who received the affected lots.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Puerto Rico, Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, Honduras, Trinidad-Tobago, St. Vincent, Bahamas, Panama, and Cayman Islands.
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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