Recall Z-2110-2011 ยท KHE Reagent, Occult Blood
Alere North Americal
Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory) Product Part Number: 8116KCV Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
| Date | Apr 28, 2011 (initiated Mar 21, 2011) |
| Status | Terminated |
| Reason | Potential for false negatives test results and negative/faint positive controls |
| 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 si |
| Quantity | 1800 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063693 | FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST New Bay Bioresearch Co. , Ltd., May 11, 2007 |