Recall Z-0894-05 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Abbott Health Products, Inc.
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
| Date | Jun 16, 2005 (initiated Mar 24, 2005) |
| Status | Terminated |
| Reason | 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. |
| 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 provider |
| Quantity | 793 kits |
| Distribution | US Goverment, Domestic and International distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912535 | IMX TOTAL B-HCG Abbott Laboratories, Jul 1, 1991 |