# FDA recall Z-0077-2019

> **Instrumentation Laboratory Co.** · Class II · device recall initiated 2018-08-01.

## Product

Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage -  HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

## Reason for recall

There is a potential for increased imprecision, out of range quality controls and prolonged sample results.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-0077-2019
- **Recalling firm:** Instrumentation Laboratory Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-01
- **Report date:** 2018-10-17
- **Termination date:** 2019-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bedford, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0077-2019

## Citation

> AI Analytics. FDA recall Z-0077-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0077-2019. Source: US FDA. Licensed CC0.

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