Z-1067-2007

AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one...

Name: Z-1067-2007 AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one...
Creator: Abbott Diagnostic International, Ltd.
Published: 2007-04-10
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2007-04-10 / Terminated

FDA source

Abbott Diagnostic International, Ltd. began a recall of AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate... on 2007-04-10. The reason FDA records is "An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1067-2007
Status: Terminated
Initiated: 2007-04-10
Posted: 2007-07-12
Terminated: 2012-02-14
Recalling firm: Abbott Diagnostic International, Ltd.
Product: AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7A59-21. 100 Tests. For In Vitro Diagnostic Use.
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or Dilution Inaccuracy.
FDA root cause: Other
Action: The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.
Quantity in commerce: 11530 kits
Distribution: Worldwide, including USA, PR, USVI, CANADA, MEXICO, GUATEMALA, COSTA RICA, COLOMBIA, ECUADOR, PERU, CHILE, URUGUAY, ARGENTINA, BRAZIL, DOMINICAN REPUBLIC, EL SALVADOR, GERMANY, JAPAN, SINGAPORE, HONG KONG, TAIWAN, THAILAND, SOUTH KOREA, AUSTRALIA, NEW ZEALAND, HONDURAS, TRINIDAD & TOBAGO, GRENADA, ST. VINCENT, ST. LUCIA, ANTIGUA, BARBADOS, CURACAO, BRITISH VIRGIN ISLANDS, BAHAMAS, PANAMA, and CAYMAN ISLANDS.
Product codes and lots: 46329Q101, 47118Q101, 48063Q101, 48065Q101, 49341Q101, 49559Q101

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)