Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott park, IL 60064
This recall has been terminated (originally issued April 16, 2003).
- Company
- Abbott Laboratories Hpd/Add
- Recall Initiated
- March 4, 2003
- Posted
- April 16, 2003
- Terminated
- September 4, 2003
- Recall Number
- Z-0726-03
- Quantity
- 107 kits
- Firm Location
- Abbott Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values
Distribution
Nationwide
Lot / Code Info
lot number 89651M300, exp. 04/20/03
Root Cause
Other
Action Taken
Recalled by letter dated 3/4/03. The laboratory accounts were informed of the lot of calibrators causing depressed values for the IMx AFP Low Control, requested to destroy any of the suspect lot of calibrators, and recalibrate the AFP assay using a different lot of calibrators.
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