Abbott m2000sp — Class II medical device recall Z-0463-2015
Terminated recall by Abbott Molecular, reported 2014-12-03, distributed nationwide. Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6
| Recall number | Z-0463-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Des Plaines, IL, United States |
| Recall initiated | 2014-10-23 |
| Classified | 2014-11-25 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2016-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CO, CR, DE, DK, DZ, EG, ES, FI, FR, GB, GR, HK, HN, HR, ID, IE, IL, IN, IT, JP, KE, KR, LT, MX, NG, NL, NO, NZ, PK, PL, PT, PY, RO, RU, SA, SE, SI, TH, TR, TW, UA, VN, ZA |
| Reason classes | software |
Product
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Reason for recall
Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the Available Reagent Packs screen is selected.
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-0463-2015. 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.