Abbott Laboratories HPD/ADD Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbott Park, IL 60064 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbott Park, IL 60064
Brand
Abbott Laboratories HPD/ADD
Lot Codes / Batch Numbers
list 3B42-50, lot 86504M300
Products Sold
list 3B42-50, lot 86504M300
Abbott Laboratories HPD/ADD is recalling Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with due to The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
Recommended Action
Per FDA guidance
Recalled by letter dated 3/4/03. The accounts were informed of the depressed values for the CA 15-3 High Control and for patient specimens, and were requested to discontinue use and destroy any of the three affected lots found in inventory.
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