Abbott Health Products, Inc. AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent.
Brand
Abbott Health Products, Inc.
Lot Codes / Batch Numbers
2614Q100 (5/13/2005), 26278Q100, 26381Q100 (6/21/2005)
Products Sold
2614Q100 (5/13/2005); 26278Q100, 26381Q100 (6/21/2005)
Abbott Health Products, Inc. is recalling AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline due to Abbott Diagnostics is investigation a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when usin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Abbott Diagnostics is investigation a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when using AxSYM Total B-hCG reagent lots. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
Recommended Action
Per FDA guidance
Abbot Health Products, Inc. informed and instructed their customers via Device Recall Letter to Identify if they have used or have inventory of the affected product. Discontinue use of and destroy any remaining inventory of reagent lots listed in the Device Recall letter according to their laboratory procedures. Record the quantity of the recalled reagents currently in inventory in their facility that will be destroyed on the attached reply form and fax the form back to Abbott 1-800-777-0051. (US only) Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.
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