FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-2110-2011
- Recalling firm
- Alere North Americal
- Product
- 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
- Status
- Terminated
- Initiated
- 2011-03-21
- Posted
- 2011-04-28
- Terminated
- 2013-03-07
- 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 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
- 1800 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot Numbers: 0626510 0805110
- 510(k) numbers
- ["K063693"]
- PMA numbers
- not on file
- Product code
- KHE
- Firm FEI
- 3006984151
- Firm city
- Orlando
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28