IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluent

Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. 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.

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.