Recall Z-0893-05 ยท JHI Visual, Pregnancy Hcg, Prescription Use
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.
| Date | Jun 16, 2005 (initiated Mar 24, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 provide |
| Quantity | 2496 |
| Distribution | Domestic , US Goverment and International ditribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935673 | AXSYM TOTAL B-HCG Abbott Laboratories, Jun 21, 1994 |