Recall record at a glance
| Official record | Z-1345-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Menarini Silicon Biosystems |
| Report date | Jul 13, 2022 |
| Recall initiation date | May 20, 2022 |
| Quantity | 484 units |
| Location | Huntingdon Valley, PA, United States |
Official product description
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: 7900001
Why the product was recalled
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 information
CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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