Origio Sperm Wash
Brand(s)
Last updated
Summary
Product
Origio Sperm Wash
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Origio Sperm Wash | 230922-018009 | 84055060D |
Issue
During testing it was found that one of the batches, had an insufficient concentration of sodium pyruvate - only 0.002 mg/ml compared to a specified concentration of 0.046-0.137 mg/ml (1.5-4.3% of the specified amount). Part of this formulation batch had also been used to create three lots of commercially released sperm wash medium.
Recall start date: January 22, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Obstetrics and gynaecology
Companies
| Origio A/S |
| Knardrupvej 2, Malov, Denmark, 2760 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75188
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