# FDA recall Z-0895-2018

> **Instrumentation Laboratory Co.** · Class II · device recall initiated 2017-08-02.

## Product

Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

## Reason for recall

Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.

## Distribution

Worldwide Distribution - US Nationwide

## Key facts

- **Recall number:** Z-0895-2018
- **Recalling firm:** Instrumentation Laboratory Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-02
- **Report date:** 2018-03-14
- **Termination date:** 2019-03-29

- **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-0895-2018

## Citation

> AI Analytics. FDA recall Z-0895-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0895-2018. Source: US FDA. Licensed CC0.

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