أجهزة طبية
HemosIL AcuStar HIT-IgG(PF4-H)
Summary
| Type | Health product recall |
|---|---|
| Product | HemosIL AcuStar HIT-IgG(PF4-H) |
| Issue | Medical devices - Performance |
| What to do | Contact the manufacturer if you require additional information. |
| Audience | Healthcare |
| Brand(s) | INSTRUMENTATION LABORATORY CO. |
| Last updated | 2026-10-15 |
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
HemosIL AcuStar HIT-IgG(PF4-H) |
B38062 |
0009800127 |
Issue
A performance issue was identified with HemosIL AcuStar HIT-lgG(PF4-HL ) for the Lot B38062. This performance issue may result in a negative analytical bias and calibration-related failures. Therefore, the Lot B38062 is being recalled and removed from the market as a precautionary measure.
Details
| Original published date | 2026-10-15 |
|---|---|
| Alert / recall type | Health product recall |
| Category | Health products - Medical devices - Chemistry |
| Companies | Instrumentation Laboratory Co. 180 Hartwell Road, Bedford, Massachusetts, United States, 01730-2443 |
| Published by | Health Canada |
| Audience | Healthcare |
| Recall class | Type II |
| Recall date | 2026-09-29 |
| Identification number | RA-82787 |
Source: Government of Canada, Recalls and safety alerts – https://recalls-rappels.canada.ca/en/alert-recall/hemosil-acustar-hit-iggpf4-h