The Abbott m2000sp is an automated system for performing sample… — Class II medical device recall Z-0948-2015
Terminated recall by Abbott Molecular, reported 2015-01-21, distributed in CA, FL, GA, IL, MI, NC, NJ, NY…. The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact
| Recall number | Z-0948-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Des Plaines, IL, United States |
| Recall initiated | 2013-11-23 |
| Classified | 2015-01-09 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2017-12-04 |
| Distributed | CA, FL, GA, IL, MI, NC, NJ, NY, OH, OK, OR, TX |
| Countries outside the US | AT, AU, BE, BR, CA, CN, CO, CR, DE, DK, DO, EG, FI, FR, GB, ID, IE, IL, IT, KE, KR, MA, MX, NG, NO, NZ, PK, PL, RU, SA, TH, TR, TW, UA, ZA |
| Quantity | 176 devices |
| Reason classes | device malfunction |
| Serial numbers | 1004, 1005, 10142, 10154, 10171, 10416, 10664, 10833 |
Product
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
Reason for recall
The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.
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-0948-2015. 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.