Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8111KCV (30 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
Recall
- Recall Number
- Z-2106-2011
- Event Number
- 58407
- Firm
- Alere North Americal 30 S Keller Rd Ste 100 Suite 100 Orlando FL 32810-6297
- FEI Number
- 3006984151
- Product Code
- KHE
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 21, 2011
- Posted
- April 28, 2011
- Terminated
- March 7, 2013
Description
Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8111KCV (30 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
Potential for false negatives test results and negative/faint positive controls
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.
Nationwide Distribution
6249 kits