Abbott Health Products, Inc.: AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21

Recall number

Z-0006-05

Recalling firm

Abbott Health Products, Inc.

Product

AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21

Status

Terminated

Initiated

2004-08-24

Posted

2004-10-05

Terminated

2005-07-21

Reason

Assay may give elevated patients results.

Root cause

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

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.

Lot, serial or model codes

Lot #: 18357Q100, 18357Q101 (France), 18357Q102, 18357Q103 and 18357104(France). Exp. date 11/11/04

510(k) numbers

["K935673"]

PMA numbers

not on file

Product code

JHI

Firm FEI

2623532

Firm city

Barceloneta

Firm state

not on file

Firm country

PR

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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