Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory) Product Part Number: 8116KCV Intended Use: Im

FDA device recall Z-2110-2011 · posted 2011-04-28 · Terminated

Recall details

Recalling firm

Alere North Americal

Reason for recall

Potential for false negatives test results and negative/faint positive controls

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.

Root cause

Other

Status

Terminated

Product code

KHE

Quantity affected

1800 units

Distribution

Nationwide Distribution

Date initiated

2011-03-21

Date posted

2011-04-28

Date terminated

2013-03-07

Location

Orlando, FL

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