FDA Device

AxSYM Total B-hCG Reagent Pack

Hazard

Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.

What You Should Do

Remedy

Device recall letters dated 7/7/04 were sent to all customers. Customers were instructed to identify if they have used, are currently using, or have inventory of the AxSYM Total B-hCG Reagent lots. Discontinue use of and destroy any remaining inventory of the lots according to their laboratory procedures. Record the quantity currently in their facility that will be destroyed on the attached reply form and fax the form to Abbott at 1-800-777-0051 (U.S. only). Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.

Products

AxSYM Total B-hCG Reagent Pack
Brand
Abbott Health Products, Inc.
UPC
Lots numbers: 17202Q100 (expiration date 09/23/2004),  17556Q100 (expiration date 10/17/2004), and 17387Q100 (France) (expiration date 08/23/2004).

Units Affected

5617 kits