Z-2200-2010

International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation...

Name: Z-2200-2010 International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation...
Creator: International Technidyne Corp.
Published: 2010-06-25
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2010-06-25 / Terminated / root cause: manufacturing process

FDA source

International Technidyne Corp. began a recall of International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic... on 2010-06-25. The reason FDA records is "The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2200-2010
Status: Terminated
Initiated: 2010-06-25
Posted: 2010-08-10
Terminated: 2010-09-23
Recalling firm: Accriva Diagnostics, Inc.
Product: International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic 15 vials For performance of Level 1 quality control ACT-LR test cuvettes on the Hemochron Microcoagulation Systems.
Product code: GGN Plasma, Coagulation Control
Reason for recall: The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ITC sent Urgent Medical Device Correction letters on June 25, 2010 by Federal Express to hospital Risk Managers and Lab Directors, Clinical Laboratory Manager or Point-of-Care Coordinators.
Quantity in commerce: 122 boxes in US, 1 out of US.
Distribution: Nationwide and one customer in Belgium.
Product codes and lots: Catalog number: DCJLR-N; Lot number: M9DNL055, exp. 9/2010

Product code GGN

K944691Class IIItc Whole Blood Control Normal/abnormal Level I or IIInternational Technidyne Corp. / cleared 1995-03-15

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)