Recall Z-2107-2011
Alere North Americal · initiated March 21, 2011
Product
Clearview iFOB, Clearview - Sample Kit (5 Test)Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8112KCV (5 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
Codes / lots: Lot Number: 0630010
Reason for recall
Potential for false negatives test results and negative/faint positive controls
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2107-2011
- Initiated
- March 21, 2011
- Posted by FDA
- April 28, 2011
- Terminated
- March 7, 2013
- Product code
- KHE – Reagent, Occult Blood
- Quantity
- 1500 kits
- Distribution
- Nationwide Distribution
- Recalling firm
- Alere North Americal, Orlando, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2106-2011 | Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test…Potential for false negatives test results and negative/faint positive controls | 03/21/2011Terminated |
| Z-2108-2011 | Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (25 Test) Immunochemical Fecal…Potential for false negatives test results and negative/faint positive controls | 03/21/2011Terminated |
| Z-2109-2011 | Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal…Potential for false negatives test results and negative/faint positive controls | 03/21/2011Terminated |
| Z-2110-2011 | Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory) Product Part…Potential for false negatives test results and negative/faint positive controls | 03/21/2011Terminated |
| Z-2111-2011 | Clearview iFOB, Clearview - Clearview iFOB Return Mailer(accessory) Product Part Number:…Potential for false negatives test results and negative/faint positive controls | 03/21/2011Terminated |