AxSYM Total B-hCG Reagent Pack
FDA Recall Z-1436-04 · Posted 2004-09-02
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Recalling FirmAbbott Health Products, Inc.
Recall StatusTerminated
Product CodeJHI
Date Initiated2004-07-07
Date Terminated2004-12-01
Product Quantity5617 kits
Reason for Recall
Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.
Firm Action
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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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