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Regenkit® bct-3

Official notice

21 Dec 2022

Last checked

21 Dec 2022

Medium riskHealth Canada

An official Health Canada notice concerns Regenkit® bct-3. 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 Published 2022-12-21.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72394

Official notice

2022-12-21

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

72394

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Affected products

Product 1

Affected products - RegenKit® BCT-3, Lot or serial number - 303 301 308 309, Model or catalog number - BCT-3

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Regen Lab, Regenkit® Bct-3.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

72394

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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