Reported Feb 27, 2013 · Terminated

Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne…

International Technidyne Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: International Technidyne Corp. · 68 Olsen Ave · Edison, NJ · 08820-2419

Is this the product you have?

Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.

Lot codes and dates: 152 of 152 codes
Pro3-25
A2K3C001
1/31/2013
A2K3C002
1/31/2013
A2P3C003
1/31/2013
A2P3C004
1/31/2013
A2K3C005
1/31/2013
A2K3C006
1/31/2013
A2K3C007
1/31/2013
A2K3C008
1/31/2013
A2K3C009
1/31/2013
A2K3C011
1/31/2013
A2K3C013
1/31/2013
A2K3C015
1/31/2013
A2K3C016
1/31/2013
A2K3C017
1/31/2013
A2K3C018
1/31/2013
A2K3C019
1/31/2013
A2K3C020
1/31/2013
A2K3C021
1/31/2013
A2K3C022
1/31/2013
A2K3C023
1/31/2013
A2K3C0241/31/2013
A2K3C025
1/31/2013
A2K3C026
1/31/2013
A2K3C027
1/31/2013
B2K3C028
2/28/2013
B2K3C030
2/28/2013
B2K3C031
2/28/2013
B2K3C032
2/28/2013
B2K3C033
2/28/2013
B2K3C034
2/28/2013
Amount recalled: 11,742 boxes US (25 cuvettes per box); 22,968 boxes OUS (25 cuvettes per box)

Where it was sold

Nationwide

Why it was recalled

Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new International Technidyne Corp. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.

By hazard

Medical device recalls

All recall categories · Browse the whole archive