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Terminated

International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol.

FDA Recall Z-0470-2007 · Posted 2007-01-13

Recalling FirmInternational Technidyne Corp.
Recall StatusTerminated
Product CodeGJS
Date Initiated2006-12-06
Date Terminated2007-04-26
Product Quantity1,541 units

Reason for Recall

Incorrect Test Results-ProTime ITC''s Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send or PRINT RESULTS feature.

Firm Action

Medical Device Correction letters were sent on 12/6/2006 by first class mail along with a replacement Operator's manual. On 3/19/07 the firm sent and additional letter to customers in order to ensure that self testers, as well as health care professionals and distributors were notified.

Root Cause

Other

Distribution Pattern

Nationwide to health care professionals and ITC distributors

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K951072PROTIME MICROCOAGULATION SYSTEMInternational Technidyne Corp. · 1995-10-27

Official Source

View FDA Recall →

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

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