FDA Device recall Z-0634-2013
Abbott m2000sp Instrument
- FDA Device
- Class II
- terminated
- Published 2013-01-09
On 2013-01-09 the FDA classified a Class II recall of Abbott m2000sp Instrument by Abbott Molecular, citing 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 Extr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0634-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-04 |
| Published | 2013-01-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Molecular |
| Distribution | US |
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
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.
Identifiers
| code_info | list 09K14, all serial numbers and all software versions 1.0 - 5.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0634-2013%22
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