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***.''
FDA Recall Z-0171-06 · Posted 2005-11-18
Recalling FirmProvalis Diagnostics
Recall StatusTerminated
Product CodeLCP
Date Initiated2005-05-20
Date Terminated2012-05-03
Product Quantity838 Kits of 10 test devices each
Reason for Recall
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.
Firm Action
All consignees were initially notified by telephone with followup by FAX or email. Users/Distributors may also be visited by Provalis Sales Staff.
Root Cause
Other
Distribution Pattern
Distributed to 7 Consignees in the US one each in FL, KY, IL, LA, MI, AZ, GA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.