West Nile Virus IgM Capture ELISA The Panbio West Nile Virus IgM Capture ELISA is for the qualitative presumptive detect

FDA device recall Z-1014-2012 · posted 2012-02-14 · Terminated

Recall details

Recalling firm

Inverness Medical

Reason for recall

It has come to our attention that users of these product lots may experience an elevation in the rate of false positivity when compared with previous product lots. Internal quality assurance testing has shown that the products are performing within the release specifications, although there has been a slight shift in the cut-off which may lead to an increase in the number of positive results obta

Action taken

Inverness Medical sent an Urgent In Vitro Diagnostic Recall letter dated October 6, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use, destroy any unused or partially used test kits of the affected lot(s), and complete the table and certification of compliance. Customers were asked to fax back the completed form to inverness Medical at 1-609-527-8054. Replacement stock would be forwarded to them at no cost when the new lot becomes available. For questions regarding this recall call 609-627-8038.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NOP

Quantity affected

289 Kits

Distribution

Worldwide Distribution including ND, PA, TX, MN; and the country of Canada

Date initiated

2008-10-08

Date posted

2012-02-14

Date terminated

2012-02-15

Location

Park, Sinnamon, Australia

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