ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064
- Company
- Abbott Laboratories Hpd/Add/Gprd
- Recall Initiated
- December 15, 2003
- Posted
- July 20, 2004
- Terminated
- July 22, 2004
- Recall Number
- Z-0353-04
- Quantity
- 1,364 kits
- Firm Location
- Abbott Park, IL
Reason for Recall
The calibrator lots may yield Free T4 values that are depressed.
Distribution
Nationwide and internationally to Abbott subsidiaries in Brazil, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Colombia, New Zealand, Venezuela and Taiwan.
Lot / Code Info
lots 94493M300 and 94493M301
Root Cause
Other
Action Taken
Architect Free T4 Calibrator kits were recalled by letter dated 12/15/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the kits, and were requested to discontinue use and destroy the affected lots of product.
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