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***.'' Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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***.''
Brand
Provalis Diagnostics
Lot Codes / Batch Numbers
Device Lot 03793, 03952, 04080, 04128, 04208, 04209, 04321, 04323, 04464, 05040.
Products Sold
Device Lot 03793, 03952, 04080, 04128, 04208, 04209, 04321, 04323, 04464, 05040.
Provalis Diagnostics is recalling Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridge due to Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being fou. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
All consignees were initially notified by telephone with followup by FAX or email. Users/Distributors may also be visited by Provalis Sales Staff.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, FL, GA, IL, IN, KY, LA, MI
Page updated: Jan 10, 2026