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U.S. Department of Health and Human Services

Class 2 Device Recall AxSYM Total BhCG

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  Class 2 Device Recall AxSYM Total BhCG see related information
Date Initiated by Firm July 07, 2004
Date Posted September 02, 2004
Recall Status1 Terminated 3 on December 01, 2004
Recall Number Z-1436-04
Recall Event ID 29623
510(K)Number K935673  
Product Classification Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
Product AxSYM Total B-hCG Reagent Pack
Code Information Lots numbers: 17202Q100 (expiration date 09/23/2004),  17556Q100 (expiration date 10/17/2004), and 17387Q100 (France) (expiration date 08/23/2004).
Recalling Firm/
Abbott Health Products, Inc.
Hwy 2 Km 58.0
Barceloneta PR 00617
For Additional Information Contact Nydia I. Cancel
Manufacturer Reason
for Recall
Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.
FDA Determined
Cause 2
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.
Quantity in Commerce 5617 kits
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JHI and Original Applicant = ABBOTT LABORATORIES