# FDA recall Z-2074-2020

> **Dako  Denmark A/S** · Class II · device recall initiated 2019-11-05.

## Product

Dako Autostainer instruments:   Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400;  and Autostainer Plus, Model S3800.

## Reason for recall

The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining.

## Distribution

Distribution was nationwide.   There was government/military distribution.      Foreign distribution was made to Canada,  Australia, Bangaladesh,  Belarus, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan,  Kazakhstan, Kenya, Kuwait,  Latvia, Lebanon, Macedonia, Morocco, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Poland, Qatar, Romania, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, Uruguay, and Vietnam.

## Key facts

- **Recall number:** Z-2074-2020
- **Recalling firm:** Dako  Denmark A/S
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-05
- **Report date:** 2020-05-27
- **Termination date:** 2022-05-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glostrup, N/A, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2074-2020

## Citation

> AI Analytics. FDA recall Z-2074-2020. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2074-2020. Source: US FDA. Licensed CC0.

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