Abbott m2000sp Automated Sample Preparation System Recalled for X-Drive Failure
Abbott Molecular is recalling 176 m2000sp automated sample preparation systems because the x-drive assembly may fail prematurely, potentially causing the manipulator arm to contact objects or pipet improperly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential mechanical failure leading to improper operation.
Plain-English summary
Abbott Molecular is recalling 176 units of the Abbott m2000sp automated system, which is used for performing sample preparation for nucleic acid testing. The recall is due to a potential defect in the x-drive assembly, which may fail prematurely. This failure could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.
The affected devices are identified by List Number 09K14-02, Model E-series, and specific serial numbers including 10664 through 10833, 1004, 1005, 10142, 10154, 10171, and 10416. The devices were distributed worldwide, including in the United States (California, Florida, Georgia, Illinois, Michigan, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, and Texas) and internationally to numerous countries such as Australia, Canada, China, Germany, and the United Kingdom.
The source text does not specify the exact actions consumers or healthcare facilities should take, such as contacting the manufacturer or stopping use, beyond the fact that the recall is active. Users of the affected devices should refer to the official FDA recall notice for specific instructions on how to proceed.
The recalled product
- Product
- The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
- Manufacturer
- Abbott Molecular
- Affected units
- 176
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- List Number: 09K14-02
- Model: E-series
- Serial Numbers: 10664 - 10833
- 1004
- 1005
- 10142
- 10154
- 10171
- 10416
Distribution
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