FDA Medical Device Recalls (openFDA)
International Technidyne Corporation: directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.
- Recall number
- Z-1786-2010
- Recalling firm
- International Technidyne Corporation
- Product
- directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.
- Status
- Terminated
- Initiated
- 2010-04-15
- Posted
- 2010-06-11
- Terminated
- 2010-09-23
- Reason
- Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect.
- 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
- 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.
- Lot, serial or model codes
- Catalog number.Code number: DCJPT-A; Lot number G9DPA005; Exp. 1/31/2011.
- 510(k) numbers
- ["K944691"]
- PMA numbers
- not on file
- Product code
- GGN
- Firm FEI
- 2250033
- 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
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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 b87518bfe2e8, published 2026-09-28