FDA Medical Device Recalls (openFDA)
International Technidyne Corp.: 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.
- Recall number
- Z-2200-2010
- Recalling firm
- International Technidyne Corp.
- 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.
- Status
- Terminated
- Initiated
- 2010-06-25
- Posted
- 2010-08-10
- Terminated
- 2010-09-23
- Reason
- The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes
- 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
- 122 boxes in US, 1 out of US.
- Distribution
- Nationwide and one customer in Belgium.
- Lot, serial or model codes
- Catalog number: DCJLR-N; Lot number: M9DNL055, exp. 9/2010
- 510(k) numbers
- K944691
- PMA numbers
- not on file
- Product code
- GGN
- Firm FEI
- 1000526865
- Firm city
- Edison
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06