FDA-Device2026-08-26Class IIPROCESSING DEFECT
Foundation Medicine Hamilton Microlab STAR Protocol Configuration Tool v2.0.0 recalled for software stability issue
What this means
Foundation Medicine's Protocol Configuration Tool (PCT) v2.0.0, used with Hamilton Microlab STAR liquid handlers to conduct F1CDx and F1LCDx tests, has a software issue that can cause the application to close unexpectedly. This affects 32 units distributed in Massachusetts and North Carolina.
- Contact Foundation Medicine if you operate affected equipment (Equipment IDs listed in the official recall notice)
- Do not rely on PCT v2.0.0 until you receive instructions or an updated version from Foundation Medicine
- Report any unexpected software crashes to Foundation Medicine immediately
The agency's original wording
Hazard
Software issue that can cause an increase in spontaneous software closures.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of MA & NC.
Affected count
32 units
Manufactured in
150 2nd St, Cambridge, MA, United States
Products
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2951-2026Want us to check the next one for you?
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