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Terminated

directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.

FDA Recall Z-1786-2010 · Posted 2010-06-11

Recalling FirmInternational Technidyne Corporation
Recall StatusTerminated
Product CodeGGN
Date Initiated2010-04-15
Date Terminated2010-09-23
Product Quantity94 boxes

Reason for Recall

Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K944691ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR IIInternational Technidyne Corp. · 1995-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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