Z-1786-2010

directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems

Name: Z-1786-2010 directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems
Creator: International Technidyne Corporation
Published: 2010-04-15
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2010-04-15 / Terminated / root cause: labeling and UDI

FDA source

International Technidyne Corporation began a recall of directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems on 2010-04-15. The reason FDA records is "Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1786-2010
Status: Terminated
Initiated: 2010-04-15
Posted: 2010-06-11
Terminated: 2010-09-23
Recalling firm: Accriva Diagnostics, Inc.
Product: directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.
Product code: GGN Plasma, Coagulation Control
Reason for recall: Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Notification letters were sent vis Federal Express on April 15, 2010 to all distributors and end users to return unused product or to replace the package insert. Please direct questions ITC Technical Support at phone 800-631-5945 Ext. 4707.
Quantity in commerce: 94 boxes
Distribution: Distributors and medical facilities in AZ, CA, IL, KY, MA, MD, ME, MO, PA, WA. Foreign distribution to Australia, Canada, Switzerland, Germany, Spain, Quatar, and Saudi Arabia.
Product codes and lots: Catalog number.Code number: DCJPT-A; Lot number G9DPA005; Exp. 1/31/2011.

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)