Recall Z-2460-2008 ยท LCP Assay, Glycosylated Hemoglobin
Cholestech Corp
Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c).
| Date | Sep 23, 2008 (initiated Aug 3, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 9,324 Cartridges |
| Distribution | U.S. state of Colorado. OUS: India, Slovenia, Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041635 | G5 I HBA1C TEST, G5 II HBA1C TEST Provalis Diagnostics , Ltd., Aug 16, 2004 |