Z-0535-2020 Class II Terminated
FDA device recall Z-0535-2020 was initiated by Foundation Medicine, Inc. on Aug 8, 2019 and is designated Class II. Reason for recall: Identified potential false positive MSI-H on the test reports provided to the physicians. The recall status is terminated (terminated Jul 19, 2021). Affected quantity: 8 reports.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2019
- Initiation Date
- Aug 8, 2019
- Termination Date
- Jul 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 reports
Product Description
FoundationOne CDx test report
Reason for Recall
Identified potential false positive MSI-H on the test reports provided to the physicians.
Distribution Pattern
MA, NC,IN, OH, GA
Code Information
Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0535-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026