Foundation Medicine Recalls Hamilton Microlab STAR Liquid Handler Software
Foundation Medicine is recalling 32 Hamilton Microlab STAR Liquid Handler units due to a software issue causing spontaneous closures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Foundation Medicine, Inc. is recalling 32 units of the Hamilton Microlab STAR Liquid Handler, specifically the Protocol Configuration Tool (PCT) v2.0.0 software. This equipment is used to conduct F1CDx and F1LCDx tests. The recall is due to a software issue that can cause an increase in spontaneous software closures.
The affected units were distributed nationwide in the United States, specifically in the states of Massachusetts and North Carolina. The recall covers specific equipment IDs listed in the agency's documentation.
Consumers and healthcare facilities should contact Foundation Medicine, Inc. for instructions on how to address the software issue. No specific consumer action is detailed in the source text beyond the recall notification.
The recalled product
- Product
- Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
- Manufacturer
- Foundation Medicine, Inc.
- Hazard
- Affected units
- 32
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 (20)
- Software Version: Protocol Configuration Tool (PCT) v2.0.0
- Equipment ID: 100071
- 100213
- 100355
- 102281
- 103047
- 104154
- 104201
- 104202
- 104204
- 104205
- 104224
- 104503
- 104504
- 104562
- 104885
- 105961
- 106497
- 00016
- 00487
Distribution
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