Foundation Medicine, Inc.: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Recalling firm
- Foundation Medicine, Inc.
- Product
- Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
- Reason
- Software issue that can cause an increase in spontaneous software closures.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-10
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of MA & NC.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/bc50ce4a-7e97-4fa2-88da-a6b6e38567c4