Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Conten

FDA device recall Z-0245-2008 · posted 2007-11-21 · Terminated

Recall details

Recalling firm

Applied Biotech Inc

Reason for recall

Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.

Action taken

A Product Recall Notification dated 9/28/2006, was provided via fax, email or direct mail to all primary consignees. Customers were instructed to block all stock of affected lots in their warehouses, contact their primary consignees and advise them to discontinue use immediately and dispose of any unused materials; using a fax back form to communicate to the recalling firm the quantity blocked and disposed of so that arrangements could be made for providing replacement product

Root cause

Process design

Status

Terminated

Product code

JHI

Quantity affected

3,238 Kits (97,140 tests)

Distribution

Worldwide: USA and Canada

Date initiated

2006-09-28

Date posted

2007-11-21

Date terminated

2012-08-03

Location

San Diego, CA