أجهزة طبية
Plateletworks Collagen Kit
Summary
| Type | Health product recall |
|---|---|
| Product | Plateletworks Collagen Kit |
| Issue | Medical devices - Performance |
| What to do | Contact the manufacturer if you require additional information. |
| Audience | Healthcare |
| Brand(s) | Helena Laboratories, Corp |
| Last updated | 2026-11-04 |
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Plateletworks Collagen Kit |
3-26 (3-26-552076) |
5852 |
Issue
This recall is being issued due to poor aggregation with collagen tubes from this lot. Internal testing of tubes from this lot with normal donor blood showed 5 of 8 definitively abnormal, 1 equivocal, 2 normal. Because the effect varies from tube to tube, a kit from this lot that passes in-house quality control may still contain affected tubes.
A tube from this lot may give a falsely low percent aggregation with collagen, which could suggest abnormal platelet function when function is normal. As stated in the procedure insert, any questionable test result should be repeated and performed in duplicate, and results should be interpreted in light of the patient's clinical history and condition.
Details
| Original published date | 2026-11-04 |
|---|---|
| Alert / recall type | Health product recall |
| Category | Health products - Medical devices - Haematology |
| Companies | Helena Laboratories, Corp 1530 Lindbergh Drive, Beaumont, Texas, United States, 77707 |
| Published by | Health Canada |
| Audience | Healthcare |
| Recall class | Type II |
| Recall date | 2026-10-21 |
| Identification number | RA-82907 |
Source: Government of Canada, Recalls and safety alerts – https://recalls-rappels.canada.ca/en/alert-recall/plateletworks-collagen-kit