FDA Medical Device Recalls (openFDA)
International Technidyne Corp.: Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box. Mfg. by International Technidyne Corp, Edison, NJ 08820.
- Recall number
- Z-1381-05
- Recalling firm
- International Technidyne Corp.
- Product
- Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box. Mfg. by International Technidyne Corp, Edison, NJ 08820.
- Status
- Terminated
- Initiated
- 2005-04-27
- Posted
- 2005-08-23
- Terminated
- 2005-08-25
- Reason
- Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.
- Root cause
- Other
- Action
- Recall letter was sent out on 4/27/2005 via First Class Mail.
- Quantity
- 924 boxes x 45 cuvettes per box
- Distribution
- Products were distributed domestically to customers nationwide. Products were also distributed internationally to customers in the following countries: Italy, Sweden, Norway, Germany, and Japan. Products were distributed to the VA Medical Center, Los Angeles, CA 90073.
- Lot, serial or model codes
- Catalog No. JACT-LR Lot No''s: M4JLR164, Exp. 3/2006; M4JLR165, Exp. 3/2006; A5JLR001, Exp. 4/2006; A5JLR002, Exp. 4/2006; A5JLR003, Exp. 4/2006; C5JLR032, Exp. 6/2006.
- 510(k) numbers
- ["K960749"]
- PMA numbers
- not on file
- Product code
- JBP
- 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
- 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