CALiaGold PierceTube
Brand(s)
Last updated
Summary
Product
CALiaGold PierceTube
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 catalog number |
|---|---|---|
| CALiaGold PierceTube | 40045 31390 40037 | 1151300 |
Issue
Following a customer complaint, Sentinel detected a defect in three (3) lots of the collection tube CALiaGold PierceTube, ref. 1151300: lot 31390, 40037, 40045. The defect is an inner plastic crack that connects the two chambers of the collection tube, causing a reduction of the buffer volume needed for the measurement. It cannot be excluded that a significant volume decrease may lead to the impossibility to perform the test. The root cause of the plastic crack is still under investigation.
Recall Start Date: June 13, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Sentinel Ch. Spa
Via Robert Koch, 2, Milan, Italy, 20152
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75788
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