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***.''
- Company
- Provalis Diagnostics
- Recall Initiated
- May 20, 2005
- Posted
- November 18, 2005
- Terminated
- May 3, 2012
- Recall Number
- Z-0171-06
- Quantity
- 838 Kits of 10 test devices each
- Firm Location
- Orlando, FL
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.
Distribution
Distributed to 7 Consignees in the US one each in FL, KY, IL, LA, MI, AZ, GA.
Lot / Code Info
Device Lot 03793, 03952, 04080, 04128, 04208, 04209, 04321, 04323, 04464, 05040.
Root Cause
Other
Action Taken
All consignees were initially notified by telephone with followup by FAX or email. Users/Distributors may also be visited by Provalis Sales Staff.