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.
FDA Recall Z-1381-05 · Posted 2005-08-23
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Recalling FirmInternational Technidyne Corp.
Recall StatusTerminated
Product CodeJBP
Date Initiated2005-04-27
Date Terminated2005-08-25
Product Quantity924 boxes x 45 cuvettes per box
Reason for Recall
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.
Firm Action
Recall letter was sent out on 4/27/2005 via First Class Mail.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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