Z-2109-2011

Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal Occult Blood...

Name: Z-2109-2011 Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal Occult Blood...
Creator: Alere North Americal
Published: 2011-03-21
License: https://open.fda.gov/license/

Abbott Rapid Dx North America, LLC / initiated 2011-03-21 / Terminated

FDA source

Alere North Americal began a recall of Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8115KCV (25 Test Kit... on 2011-03-21. The reason FDA records is "Potential for false negatives test results and negative/faint positive controls". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2109-2011
Status: Terminated
Initiated: 2011-03-21
Posted: 2011-04-28
Terminated: 2013-03-07
Recalling firm: Abbott Rapid Dx North America, LLC
Product: Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8115KCV (25 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
Product code: KHE Reagent, Occult Blood
Reason for recall: Potential for false negatives test results and negative/faint positive controls
FDA root cause: Other
Action: Alere sent a Voluntary Product Recall letter dated March 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to indicate zero on the attached Recall Reply Form, sign, and fax to 1-877-877-0147, if they have no remaining product. For any remaining product customers were instructed to discontinue use and indicate the quantity of kits in the attached Recall Reply Form so that the firm can arrange for them to receive credit. Customers were instructed to destroy any affected units at their site. For any further distribution of product, customers will need to be contacted. Physicians and hospitals were advised to retest patients with negative results. Questions relating to this Voluntary Product Recall call 1-877-597-9586.
Quantity in commerce: 1594 kits
Distribution: Nationwide Distribution
Product codes and lots: Lot Numbers: 0626810 0808110

Product code KHE

K063693Class IIForsure One Step Fecal Occult Blood (Fob) Screen Card TestNew Bay Bioresearch Co. , Ltd. / cleared 2007-05-11

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)