Recall Z-0171-06 ยท LCP Assay, Glycosylated Hemoglobin
Provalis Diagnostics
Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product is labeled in part: ''in2it In-Office analyzer A1C Test Cartridges***For the rapid quantification of hemoglobin A1c in whole blood***Provalis Diagnostics***.''
| Date | Nov 18, 2005 (initiated May 20, 2005) |
| Status | Terminated |
| Reason | Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges. |
| Root cause | Other |
| Action | All consignees were initially notified by telephone with followup by FAX or email. Users/Distributors may also be visited by Provalis Sales Staff. |
| Quantity | 838 Kits of 10 test devices each |
| Distribution | Distributed to 7 Consignees in the US one each in FL, KY, IL, LA, MI, AZ, GA. |
| 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 |