Reported Jan 9, 2013 · Terminated
Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid…
Abbott Molecular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Molecular · 1300 E Touhy Ave · Des Plaines, IL · 60018-3315
Is this the product you have?
7 of 7 products
| # | Product as published |
|---|---|
| 1 | Abbott m2000sp Instrument |
| 2 | an automated fluid handling system for performing sample preparation for nucleic acid testing |
| 3 | Abbott Molecular Inc., Des Plaines, IL 60018 USA |
| 4 | Abbott m2000sp Instrument |
| 5 | an automated system for performing sample preparation for nucleic acid testing |
| 6 | Abbott Molecular Inc., Des Plaines, IL 60018 USA |
| 7 | list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories. |
- Lot codes and dates
- list 09K14, all serial numbers and all software versions 1.0 - 5.0
- Amount recalled
- 215 units - U.S., 693 units - ROW
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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