Z-0546-2008

ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Technidyne...

Name: Z-0546-2008 ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Technidyne...
Creator: International Technidyne Corporation
Published: 2007-11-19
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2007-11-19 / Terminated / root cause: design

FDA source

International Technidyne Corporation began a recall of ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Technidyne Corporation (ITC), Piscataway, NJ 08854 on 2007-11-19. The reason FDA records is "An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0546-2008
Status: Terminated
Initiated: 2007-11-19
Posted: 2008-01-25
Terminated: 2008-08-12
Recalling firm: Accriva Diagnostics, Inc.
Product: ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Technidyne Corporation (ITC), Piscataway, NJ 08854
Product code: GJS Test, Time, Prothrombin
Reason for recall: An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 3,482 units
Distribution: 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.
Product codes and lots: All instruments with Serial Number V56560 or lower.

Product code GJS

K010599Class IIProtime Microcoagulation System / Protime 3 CuvetteInternational Technidyne Corp. / cleared 2001-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)