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Terminated

Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c).

FDA Recall Z-2460-2008 · Posted 2008-09-23

Recalling FirmCholestech Corp
Recall StatusTerminated
Product CodeLCP
Date Initiated2006-08-03
Date Terminated2009-10-07
Product Quantity9,324 Cartridges

Reason for Recall

Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life.

Firm Action

A customer notification letter was sent to Cholestech consignees who had received product from this lot. The letter dated 8/3/2006 instructed customers to discontinue use of the lot of product, destroy product according to in-house standard procedures and contact Cholestech Technical Services for replacement. It also instructed to provide a copy of the letter to other users if the lot of product was further distributed. A response form was included with instructions to complete and return. Contact Cholestech Corp at 1-510-781-3505 for assistance.

Root Cause

Nonconforming Material/Component

Distribution Pattern

U.S. state of Colorado. OUS: India, Slovenia, Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041635G5 I HBA1C TEST, G5 II HBA1C TESTProvalis Diagnostics , Ltd. · 2004-08-16

Official Source

View FDA Recall →

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

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