Z-1436-04

AxSYM Total B-hCG Reagent Pack

Name: Z-1436-04 AxSYM Total B-hCG Reagent Pack
Creator: Abbott Health Products, Inc.
Published: 2004-07-07
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2004-07-07 / Terminated / root cause: manufacturing process

FDA source

Abbott Health Products, Inc. began a recall of AxSYM Total B-hCG Reagent Pack on 2004-07-07. The reason FDA records is "Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1436-04
Status: Terminated
Initiated: 2004-07-07
Posted: 2004-09-02
Terminated: 2004-12-01
Recalling firm: Abbott Diagnostic International, Ltd.
Product: AxSYM Total B-hCG Reagent Pack
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.
Root cause tag: manufacturing process
FDA 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 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
Product codes and lots: Lots numbers: 17202Q100 (expiration date 09/23/2004), 17556Q100 (expiration date 10/17/2004), and 17387Q100 (France) (expiration date 08/23/2004).

Product code JHI

K935673Class IIAxsym Total B-HcgAbbott Laboratories / cleared 1994-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)