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Terminated

ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPST, International Technidyne Corporation (ITC), Piscataway, NJ 08854

FDA Recall Z-0547-2008 · Posted 2008-01-25

Recalling FirmInternational Technidyne Corporation
Recall StatusTerminated
Product CodeGJS
Date Initiated2007-11-19
Date Terminated2008-08-12
Product Quantity914

Reason for Recall

An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages at the point of routine Quality control checks for the Protime Microcoagulation System.

Firm Action

ITC sent to distributors, self test users and health care professionals on 11/19/07, an Urgent Medical Device Recall Letter requesting return of the devices.

Root Cause

Device Design

Distribution Pattern

Worldwide-USA and countries of China, Taiwan, Greece, Ireland, Chile, Finland, Italy, Spain, Norway, Germany, Switzerland., Singapore, Korea, Indonesia, Lichtenstein, Israel, Saudi Arabia, Latvia, Kuwait, and Slovenia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961835PROTIME MICROCOAGULATION SYSTEMInternational Technidyne Corp. · 1997-03-12

Official Source

View FDA Recall →

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

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