Cellsearch¿ Circulating Tumor Cell Kits recall
CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of…
Why was Cellsearch¿ Circulating Tumor Cell Kits recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01)10888385000012(17)180810(10)S038T (01)10888385000012(17)180810(10)S038U (01)10888385000012(17)180810(10)S038 V Serial, Batch, Lot # 2038 S038R S038S S038T S038U S038V S038W (0 distributed to the field)
- Product
- CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of…
- Recalling firm
- Menarini Silicon Biosystems
- Quantity
- N/A
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy
- Recall date
- May 2, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)