Medical Device Recall: Z-0006-05

FDA Recalls dataset · Firm: Abbott Health Products, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-08-24 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0006-05.

Recall Res Number
Z-0006-05
Recalling Firm / Manufacturer
Abbott Health Products, Inc.
FEI Number
2623532
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-08-24
Date Posted
2004-10-05
Date Terminated
2005-07-21
Product Code
JHI
Event Number
29985
Product Quantity
7830 kits
Product Description AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Reason for Recall Assay may give elevated patients results.
Action Details 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.
Distribution Pattern 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.
Code Information / Serial Numbers Lot #: 18357Q100, 18357Q101 (France), 18357Q102, 18357Q103 and 18357104(France). Exp. date 11/11/04

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