Autostainer Link 48 — Class II medical device recall Z-1261-2015
Terminated recall by Dako North America Inc., reported 2015-03-18, distributed nationwide. A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component
| Recall number | Z-1261-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dako North America Inc., Carpinteria, CA, United States |
| Recall initiated | 2015-02-12 |
| Classified | 2015-03-10 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2016-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 409 |
| Reason classes | packaging |
| Serial numbers | AS100, AS480, S3400, S3800 |
| Model numbers | AS100, AS480, S3400, S3800 |
Product
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
Reason for recall
A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800. Affected dates are from 12/2013-08/2014.
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-1261-2015. 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.