Z-0171-06

Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which...

Name: Z-0171-06 Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which...
Creator: Provalis Diagnostics
Published: 2005-05-20
License: https://open.fda.gov/license/

Provalis Diagnostics, Ltd. / initiated 2005-05-20 / Terminated

FDA source

Provalis Diagnostics began a recall of Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack... on 2005-05-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0171-06
Status: Terminated
Initiated: 2005-05-20
Posted: 2005-11-18
Terminated: 2012-05-03
Recalling firm: Provalis Diagnostics, Ltd.
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***.''
Product code: LCP Assay, Glycosylated Hemoglobin
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.
FDA 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 in commerce: 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.
Product codes and lots: Device Lot 03793, 03952, 04080, 04128, 04208, 04209, 04321, 04323, 04464, 05040.

Product code LCP

K041635Class IIG5 I Hba1c Test, G5 II Hba1c TestProvalis Diagnostics , Ltd. / cleared 2004-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)