Z-0245-2008

Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No...

Name: Z-0245-2008 Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No...
Creator: Applied Biotech Inc
Published: 2006-09-28
License: https://open.fda.gov/license/

Applied Biotech Inc / initiated 2006-09-28 / Terminated / root cause: manufacturing process

FDA source

Applied Biotech Inc began a recall of Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test... on 2006-09-28. The reason FDA records is "Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the...". 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-0245-2008
Status: Terminated
Initiated: 2006-09-28
Posted: 2007-11-21
Terminated: 2012-08-03
Recalling firm: Applied Biotech Inc
Product: Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: A Product Recall Notification dated 9/28/2006, was provided via fax, email or direct mail to all primary consignees. Customers were instructed to block all stock of affected lots in their warehouses, contact their primary consignees and advise them to discontinue use immediately and dispose of any unused materials; using a fax back form to communicate to the recalling firm the quantity blocked and disposed of so that arrangements could be made for providing replacement product
Quantity in commerce: 3,238 Kits (97,140 tests)
Distribution: Worldwide: USA and Canada
Product codes and lots: Model Number 6026KCV; ABI Lot Code: 87494

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)