FDA Medical Device Recalls (openFDA)
Abbott Health Products, Inc.: AxSYM Total B-hCG Reagent Pack
- Recall number
- Z-1436-04
- Recalling firm
- Abbott Health Products, Inc.
- Product
- AxSYM Total B-hCG Reagent Pack
- Status
- Terminated
- Initiated
- 2004-07-07
- Posted
- 2004-09-02
- Terminated
- 2004-12-01
- Reason
- Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.
- Root cause
- Other
- 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
- 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
- Lot, serial or model codes
- Lots numbers: 17202Q100 (expiration date 09/23/2004), 17556Q100 (expiration date 10/17/2004), and 17387Q100 (France) (expiration date 08/23/2004).
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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