Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HI
FDA device recall Z-0726-03 · posted 2003-04-16 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD
- 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
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LOJ
- Quantity affected
- 107 kits
- Distribution
- Nationwide
- Date initiated
- 2003-03-04
- Date posted
- 2003-04-16
- Date terminated
- 2003-09-04
- Location
- Abbott Park, IL
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