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. 의 리콜

Recall

31586

Class 3

Z-0893-05

2005-03-24

2005-06-16

Terminated

United States

2012-01-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38201

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.

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.