Reported Sep 25, 2013 · Terminated
ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated…
Assuramed
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: Assuramed · 1810 Summit Commerce Par · Twinsburg, OH · 44087
Is this the product you have?
- ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test package only); International Technidyne Corporation; 8 Olsen Avenue; Edison, NJ 08820 USA; a subsidiary of Thoratec Corporation The ProTime Microcoagulation System consists of a portable, battery operated instrument and disposable cuvette for quantitative determination of prothrombin time (PT) from fingerstick whole blood or anticoagulant-free venous whole blood. There are two different types of cuvettes available for use with
- the ProTime Microcoagulation Systema ProTime cuvette and a ProTime3 cuvette. The ProTime cuvette is black color coded and utilizes three channels for the PT assays and two channels for integral controls. It requires approximately 65 ul of blood (approximately 3 drops). The ProTime3 cuvette is blue color coded and utilizes one channel for PT assay and two channels for integral controls. The ProTime3 cuvette requires approximately 27 ul of blood (approximately 1 large drop). The ProTime Microcoagulation System is intended for professional use in the management of patients treated with oral anticoagulants or for patient self-testing
- Lot codes and dates
- *** 1)
- Product NumberPRO3-25
- LotsAll Lots
- Independence Medical Catalog Number
55L2101002*** 2)
- Product NumberPRO5-25
- LotsAll Lots
- Independence Medical Catalog NumberICPRO525
- Amount recalled
- 1) 72 units; 2) 56 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The products may have been stored at temperatures outside their required storage conditions.
This product could cause temporary or reversible health problems — stop using it.
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