FDA Device recall Z-0948-2015
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing by Abbott Molecular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0948-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-23 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Molecular |
| Distribution | CA, FL, GA, IL, MI, NC, NJ, NY, OH, OK, OR, TX |
Product
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
Reason
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.
Identifiers
| code_info | List Number: 09K14-02; Model: E-series; Serial Numbers: 10664 - 10833, 1004, 1005, 10142, 10154, 10171, 10416 |
|---|
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-0948-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.