DISCOVERY ULTRA Advanced Staining System — Class II medical device recall Z-0086-2021
Ongoing recall by Roche Diagnostics Operations, Inc., reported 2020-10-14, distributed nationwide. Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which
| Recall number | Z-0086-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2020-08-31 |
| Classified | 2020-10-08 |
| Reported by FDA | 2020-10-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IT, JO, JP, KR, KW, LT, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, RO, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, VN |
| Reason classes | packaging |
Product
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
Reason for recall
Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
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-0086-2021. 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.