# FDA recall Z-1699-2020

> **Diagnostica Stago, Inc.** · Class II · device recall initiated 2020-03-04.

## Product

STA - Deficient VIII, Product Code: 00725.  STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows:  (A) STA-R Max, Product Codes: 58989, 58990  (B) STA-R Evolution, Product Codes: 58986, 58987, 58988  (C) STA Compact Max, Product Codes: 59026, 59027  (D) STA Compact, Product Codes: 58978, 58979

## Reason for recall

A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments,  clotting times will be shortened that may cause factor VIII levels reported to be falsely increased

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1699-2020
- **Recalling firm:** Diagnostica Stago, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-04
- **Report date:** 2020-04-22
- **Termination date:** 2021-11-10

- **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-1699-2020

## Citation

> AI Analytics. FDA recall Z-1699-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-1699-2020. Source: US FDA. Licensed CC0.

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