directCHECK Whole Blood Control recallZ-1786-2010 · International Technidyne Corporation · initiated Apr 15, 2010
Terminated All recalls posted in June 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from International Technidyne Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-1786-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 15, 2010
- Posted by the FDA
- Jun 11, 2010
- Recalling firm
- International Technidyne Corporation
- Quantity
- 94 boxes
- Product code
- GGN
- FDA submissions
- K944691
- 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 description
directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.
Code information (models, lots, serial numbers)
Catalog number.Code number: DCJPT-A; Lot number G9DPA005; Exp. 1/31/2011.
Other devices under the same FDA submission
1 device cleared under K944691 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- directCHECK Whole Blood Controls DCJCPT-AAccriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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