Huntingdon Valley, PA, United States
Menarini Silicon Biosystems recalls
2 recalls recorded since 2018, most recently on 20 May 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 May 2022
- Reason
- High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples
- Distribution
- CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1345-2022
- CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number:
Terminated Class II Medical devices
- Recall started
- 4 April 2018
- Terminated
- 9 April 2019
- Reason
- Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1530-2018
- CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cyt
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.