# FDA recall Z-0738-2020

> **Diagnostica Stago, Inc.** · Class II · device recall initiated 2019-11-18.

## Product

STA  SYSTEM CONROL N + P (ref. 00678)

## Reason for recall

A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.

## Distribution

US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK

## Key facts

- **Recall number:** Z-0738-2020
- **Recalling firm:** Diagnostica Stago, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-18
- **Report date:** 2020-01-01
- **Termination date:** 2023-01-12

- **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-0738-2020

## Citation

> AI Analytics. FDA recall Z-0738-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0738-2020. Source: US FDA. Licensed CC0.

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