Assuramed Recalls ProTime Microcoagulation System Cuvettes Due to Storage Issues
Assuramed is recalling ProTime and ProTime3 cuvettes because they may have been stored at incorrect temperatures, potentially affecting test accuracy.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential test inaccuracy due to storage conditions, which is a moderate risk to patient management but does not involve direct physical injury or death.
Plain-English summary
Assuramed is voluntarily recalling ProTime Microcoagulation System cuvettes, specifically the ProTime cuvette and ProTime3 cuvette. The recall involves 72 units of Product Number PRO3-25 and 56 units of Product Number PRO5-25. These products were distributed nationwide to locations in AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH, OK, OR, SC, TX, UT, and WA.
The reason for the recall is that the products may have been stored at temperatures outside their required storage conditions. The cuvettes are intended to be stored refrigerated at 2-8C (36-36F). Improper storage may compromise the integrity of the reagents used in the quantitative determination of prothrombin time (PT).
The ProTime Microcoagulation System is intended for professional use in the management of patients treated with oral anticoagulants or for patient self-testing. Users should stop using the affected cuvettes and contact Assuramed for instructions on return or replacement. No specific lot numbers are listed, as the recall covers all lots for the specified product numbers.
The recalled product
- 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 (
- Manufacturer
- Assuramed
- Category
- Medical Device — Diagnostic Test
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- *** 1) Product Number: PRO3-25
- Lots: All Lots
- Independence Medical Catalog Number: 55L2101002
- *** 2) Product Number: PRO5-25
- Independence Medical Catalog Number: ICPRO525
Distribution
Part of a larger recall action
This product is one of 3 recalled by Assuramed under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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