# FDA recall Z-2994-2018

> **Diagnostica Stago, Inc.** · Class II · device recall initiated 2018-07-24.

## Product

Diagnostica Stago STA  N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma.  REF: 00666    The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).

## Reason for recall

QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2994-2018
- **Recalling firm:** Diagnostica Stago, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-24
- **Report date:** 2018-09-19
- **Termination date:** 2020-05-18

- **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-2994-2018

## Citation

> AI Analytics. FDA recall Z-2994-2018. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-2994-2018. Source: US FDA. Licensed CC0.

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