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Terminated

Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only).

FDA Recall Z-0657-03 · Posted 2003-03-19

Recalling FirmDigene Corp
Recall StatusTerminated
Product CodeMAQ
Date Initiated2003-02-07
Date Terminated2003-07-16
Product Quantity272 kits/ 96 assays per kit

Reason for Recall

In Vitro diagnostic test kit may produce false positive patient results

Firm Action

The firm notified consignees by phone and fax 2/7/03 and advised of potential for false positive patient results. Firms were instructed to destroy remaining inventory for replacement. Consignees were asked to return response form.

Root Cause

Other

Distribution Pattern

Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of distributed product may remain in user channels.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990023HYBRID CAPTURE II CT-ID TESTDigene Corp. · 1999-10-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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