Dako Autostainer instruments: Autostainer Link 48 — Class II medical device recall Z-2074-2020
Terminated recall by Dako Denmark A/S, reported 2020-05-27, distributed nationwide. The Autostainer instrument may not have a syringe tray installed which could result in a small volume of exces
| Recall number | Z-2074-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dako Denmark A/S, Glostrup, N/A, Denmark |
| Recall initiated | 2019-11-05 |
| Classified | 2020-05-21 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2022-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BG, BR, CA, CL, CN, CO, DE, DK, EC, EE, EG, ES, FI, FR, GR, HK, HR, IE, IL, IN, IT, JP, KE, KR, KW, LB, LV, MA, NO, NZ, OM, PA, PE, PK, PL, QA, RO, RU, SA, SE, SK, TH, TR, TW, UA, UY, VN, ZA |
| Quantity | 796 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 05700572035497 |
| Model numbers | 3400, 3800, AS100, AS480 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2074-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.