# FDA recall Z-1069-2018

> **Diagnostica Stago, Inc.** · Class II · device recall initiated 2017-10-25.

## Product

STA - Neoplastine¿ Cl Plus ¿ (ref. 00606)    Product Usage:  Manual or automated determination of the prothrombin time (PT).

## Reason for recall

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

## Distribution

Nationally

## Key facts

- **Recall number:** Z-1069-2018
- **Recalling firm:** Diagnostica Stago, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-25
- **Report date:** 2018-03-21
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1069-2018

## Citation

> AI Analytics. FDA recall Z-1069-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-1069-2018. Source: US FDA. Licensed CC0.

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