Abbott m2000sp Instrument — Class II medical device recall Z-0634-2013
Terminated recall by Abbott Molecular, reported 2013-01-09, distributed nationwide. An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes
| Recall number | Z-0634-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Des Plaines, IL, United States |
| Recall initiated | 2012-12-04 |
| Classified | 2013-01-03 |
| Reported by FDA | 2013-01-09 |
| Terminated | 2016-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, GR, HK, HN, HR, HT, ID, IE, IL, IN, IT, JP, KE, KR, LT, LU, MX, MY, NL, NO, NZ, PA, PE, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, TH, TR, TW, UA, VE, VN, ZA |
| Reason classes | potency, software |
Product
Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.
Reason for recall
An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved.
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-0634-2013. 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.