Z-1100-06

Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp...

Name: Z-1100-06 Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp...
Creator: Applied Biotech Inc
Published: 2006-05-05
License: https://open.fda.gov/license/

Applied Biotech Inc / initiated 2006-05-05 / Terminated

FDA source

Applied Biotech Inc began a recall of Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007 on 2006-05-05. The reason FDA records is "Certain kits from the product lot may contain test devices which contain incorrect reaction strips. Use of such devices may produce false negative results with patient samples at and above the limit of detection of the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1100-06
Status: Terminated
Initiated: 2006-05-05
Posted: 2006-06-09
Terminated: 2012-02-29
Recalling firm: Applied Biotech Inc
Product: Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: Certain kits from the product lot may contain test devices which contain incorrect reaction strips. Use of such devices may produce false negative results with patient samples at and above the limit of detection of the product.
FDA root cause: Other
Action: Distribution records indicate that the above product lot was produced for sale to Abbott Laboratories and Abbott Laboratories received all of the product lot. A recall certified recall letter was mailed 05/08/06. Abbott was also instructed if they have further distributed any of the referenced product lot, please see that their accounts are contacted, advise them of the urgent notification, and instruct them to destroy any of the affected product lot.
Quantity in commerce: 1198 Kits (35,940 Test)
Distribution: In US : IL
Product codes and lots: Lot# 84936

Product code JHI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)