Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
This recall has been terminated (originally issued April 24, 2003).
- Company
- Abbott Laboratories Hpd/Add
- Recall Initiated
- March 31, 2003
- Posted
- April 24, 2003
- Terminated
- August 19, 2003
- Recall Number
- Z-0782-03
- Quantity
- 368 kits
- Firm Location
- Abbott Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Lot gives lower specimen results compared to results generated with other lots.
Distribution
Nationwide, Canada, Columbia, England, Japan, Australia, New Zealand and Singapore
Lot / Code Info
list 6C26-27, lot 95651M201 list 6C26-22, lots 95651M200, 95651M202
Root Cause
Other
Action Taken
Recalled by telephone calls and follow-up letters dated 3/31/03. The accounts were informed of the depressed patient specimen results, and were requested to discontinue use and destroy any of the three affected lots found in inventory. The accounts were advised to notify physicians of the lower patient results observed with these lots and suggest review of the patient results to determine any impact on patient management.