AxSYM Total B-hCG Reagent Pack
- Company
- Abbott Health Products, Inc.
- Recall Initiated
- July 7, 2004
- Posted
- September 2, 2004
- Terminated
- December 1, 2004
- Recall Number
- Z-1436-04
- Quantity
- 5617 kits
- Firm Location
- Barceloneta, PR
Reason for Recall
Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.
Distribution
Distribution was nationwide to Laboratories and to the following government accounts: Logistic Div USAMEDAC Lab, Fort Drum, NY Keller Army Hospital Med Sup, West Point, NY VA MED CTR SUP SRV, Milwaukee, WI Weed Army Comm Hosp Lab, Fort Irwin, CA Shaw AFB 20th MDSS SGSL, Shaw AFB, SC Contr Officer, Lemoore, CA Naval Hosp, Pensacola, FL MEDCL CTR FED Prisoners, Springfield, MO Foreign countries: Japan, Singapore, Australia, New Zealand, Dominican Republic, San Salvador, Pakistan, Thailand, Honduras, Canada, Taiwan and Ge
Lot / Code Info
Lots numbers: 17202Q100 (expiration date 09/23/2004), 17556Q100 (expiration date 10/17/2004), and 17387Q100 (France) (expiration date 08/23/2004).
Root Cause
Other
Action Taken
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.