International Technidyne Corporation (ITC) directCheck… recallZ-2200-2010 · International Technidyne Corp. · initiated Jun 25, 2010
Terminated All recalls posted in August 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 Corp. 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
The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2200-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 25, 2010
- Posted by the FDA
- Aug 10, 2010
- Recalling firm
- International Technidyne Corp.
- Quantity
- 122 boxes in US, 1 out of US.
- Product code
- GGN
- FDA submissions
- K944691
- Distribution
- Nationwide and one customer in Belgium.
Product description
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.
Code information (models, lots, serial numbers)
Catalog number: DCJLR-N; Lot number: M9DNL055, exp. 9/2010
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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