Abbott Laboratories HPD/ADD 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Abbott Laboratories HPD/ADD
Lot Codes / Batch Numbers
lot number 89651M300, exp. 04/20/03
Products Sold
lot number 89651M300, exp. 04/20/03
Abbott Laboratories HPD/ADD is recalling Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreacti due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026