Abbott Laboratories HPD/ADD IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott Park, IL 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
IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott Park, IL
Brand
Abbott Laboratories HPD/ADD
Lot Codes / Batch Numbers
list 6A75-22, lot 90843M200
Products Sold
list 6A75-22, lot 90843M200
Abbott Laboratories HPD/ADD is recalling IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibra 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