# FDA recall Z-1052-2022

> **Instrumentation Laboratory** · Class II · device recall initiated 2022-04-08.

## Product

HemosIL ReadiPlasTin, Part No. 0020301400

## Reason for recall

Variable and out of specification QC results with HemosIL ReadiPlasTin.  IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.

## Distribution

US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV.

## Key facts

- **Recall number:** Z-1052-2022
- **Recalling firm:** Instrumentation Laboratory
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-08
- **Report date:** 2022-05-18

- **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-1052-2022

## Citation

> AI Analytics. FDA recall Z-1052-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1052-2022. Source: US FDA. Licensed CC0.

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