RegenKit® BCT-3
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| RegenKit® BCT-3 | 303 301 308 309 | BCT-3 |
Issue
Clients have reported several cases of patients having inflammatory reactions after injection with platelet-rich plasma (PRP), characterized by joint effusion and/or pain. Particles in the sodium citrate solution have been observed, with an irregular appearance of the separation gel and the presence of a white layer on the gel surface. To clarify, the separation gel is used for blood separation. It creates a physical barrier between the red blood cells and the PRP. Only the plasma is reinjected into the patient; the gel is not.
Recall start date: August 2, 2022
Additional information
Details
Regen Lab SA
En Budron B2, Le Mont, Switzerland, 1052
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