FDA Device recall Z-2198-2013
ProTime Microcoagulation System
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of ProTime Microcoagulation System by Assuramed, citing the products may have been stored at temperatures outside their required storage conditions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2198-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-16 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Assuramed |
| Distribution | US |
Product
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 System: a 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.
Reason
The products may have been stored at temperatures outside their required storage conditions.
Identifiers
| code_info | *** 1) Product Number: PRO3-25; Lots: All Lots; Independence Medical Catalog Number: 55L2101002; *** 2) Product N…*** 1) Product Number: PRO3-25; Lots: All Lots; Independence Medical Catalog Number: 55L2101002; *** 2) Product Number: PRO5-25; Lots: All Lots; Independence Medical Catalog Number: ICPRO525 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2198-2013%22
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