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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 August 24, 2004
Date Posted October 05, 2004
Recall Status1 Terminated 3 on July 21, 2005
Recall Number Z-0006-05
Recall Event ID 29985
510(K)Number K935673  
Product Classification Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
Product AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Code Information Lot #: 18357Q100, 18357Q101 (France), 18357Q102, 18357Q103 and 18357104(France). Exp. date 11/11/04
Recalling Firm/
Manufacturer		 Abbott Health Products, Inc.
Hwy 2 Km 58.0
Barceloneta PR 00617
For Additional Information Contact Nydia I. Cancel
787-846-8256
Manufacturer Reason
for Recall		 Assay may give elevated patients results.
FDA Determined
Cause 2		 Other
Action Device recall letters dated 8/24/2004 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 (US only). Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.
Quantity in Commerce 7830 kits
Distribution Distribution was nationwide to laboratories and to the following government accounts: 375th MEDCL GRP, Scott AFB, IL, Logistic Div USA MEDDAC, Fort Drum, NY, MED MAT SVC SGSL, Colorado Springs, CO, Naval Hosp RCVG OFCR, Charleston, SC, Keller Army Hosp MED SUP, West Point, NY, 325 MED GRP SGSL, Tyndall AFB, FL, VA Hosp Whse 90D, Miami, FL, VA MED CTR, Danville, IL, VA MED CTR, Amarillo, TX, VA MED CTR, Columbia, SC, VA MED CTR, Milwaukee, WI, 1st Med GRP, Langley AFB, VA, VA MEDCL CTR, Charleston, SC, VA MEDCL CTR, Albuquerque, NM, USH S IND Hosp., Lawton, OK, POST MED SP HSXA LOG, Fort Belvoir, VA, 366 MEDCL GRP SGSL, MTN HOME AFB, ID, Dover AFB FM, Dover AFB, DE, WEED Army COMM Hosp, Fort Irwin, CA, SHAW AFB 20th MDS SGSL, Shaw AFB, SC, William W Hasting Hosp, Tahlequah, OK, USPHS San Fidel, San Fidel, NM, Cherokee Indian Hosp, Cherokee, NC, Mount Edgecumbe Hosp, Sitka, Ak, CONTR OFFICER, Lemore, CA, FOREST CNTY POTAWATOMI, Crandon, WI, Naval Hosp, Pensacola, FL, Naval Hosp Comm OFFR, Great Lakes, IL, CONTR OFFICER, Bremerton, WA, MEDCL CTR FED PRISIONERS, Springfield, MO, PHS INDIAN HOSP, Fort Yates, ND Foreign countries: Singapore, Australia, New Zealand, Costa Rica, Ecuador, Chile, Germany, Canada, Mexico, Barbados, St. Vincent and Bermuda.
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
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