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[Recalled] The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. — The x-drive assembly may fail prematurely | FDA 2013-11-23

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductThe Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
Brand / manufacturerAbbott Molecular
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0948-2015
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date23 November 2013

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Abbott Molecular

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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