FDA Device recall Z-0463-2015
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing
- FDA Device
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class II recall of Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing by Abbott Molecular, citing 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 erro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0463-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-23 |
| Published | 2014-12-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Molecular |
| Distribution | US |
Product
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Reason
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.
Identifiers
| code_info | List Number: 09K14; Models: E series, G series |
|---|
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-0463-2015%22
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