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ConcizuTrace™ Sample Collection Kit
RANDOX LABORATORIES LIMITED · Model CZM10596 · UDI-DI 05055273218893
PQD
Prescription
0
510(k) clearances
19
Adverse events
1
Recalls
53
Facilities
Description
The Randox ConcizuTrace™ sample collection kit is used for the collection and transportation of blood samples, taken by a trained phlebotomist. The samples will be transported to a professional laboratory for testing using either the ConcizuTrace™ ELISA kit or Concizumab ELISA kit.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-16 | LetsGetChecked Inc. | Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sa |
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