Z-1392-05

ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20...

Name: Z-1392-05 ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20...
Creator: Abbott Laboratories MPG
Published: 2005-03-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-03-16 / Terminated

FDA source

Abbott Laboratories MPG began a recall of ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG... on 2005-03-16. The reason FDA records is "False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1392-05
Status: Terminated
Initiated: 2005-03-16
Posted: 2005-08-24
Terminated: 2006-05-25
Recalling firm: Abbott Medical
Product: ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, IL 60064 USA
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.
FDA root cause: Other
Action: Abbott notified their affiliates in all four countries via e-mail on 3/16/05. Each Abbott international country organization is responsible for translating the customer letter, contacting customers and determining the method of effectiveness checks based on their country requirements. The recall letters inform the accounts of the false positve results, and were requested to destroy any remaining inventory of the affected lots.
Quantity in commerce: 7607 kits
Distribution: Canada, Germany, Hong Kong and Australia
Product codes and lots: list number 7B34-16, lot numbers 16006M200 and 19199M300

Product code JHI

K965116Class IIAbbott Testpack Plus Hcg Combo with ObcAbbott Laboratories / cleared 1997-02-20

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)