HemosIL AcuStar HIT-IgG(PF4-H) Recalled Over Calibration Issues: Health Canada

Health Canada has published a Type II health product recall for a lot of the HemosIL AcuStar HIT-IgG(PF4-H) test, a medical device in the chemistry category made by Instrumentation Laboratory Co. The recall, listed under identification number RA-82787, covers Lot B38062 and carries a recall date of September 29, 2026. The notice was published on October 15, 2026, and is aimed at healthcare audiences rather than the general public.

The company is removing the affected lot from the market as a precautionary measure after a performance issue was identified. According to the notice, the problem may result in a negative analytical bias and calibration-related failures.

Recalled Products at a Glance

Only one product and one lot are named in the Health Canada notice. Details are listed below for quick reference.

• Product: HemosIL AcuStar HIT-IgG(PF4-H)
• Lot number: B38062
• Model or catalogue number: 0009800127
• Brand: Instrumentation Laboratory Co.
• Recall class: Type II
• Recall number: RA-82787
• Recall date: 2026-09-29
• Issue: Medical devices – Performance

Health Canada lists the category as Health products – Medical devices – Chemistry. The notice does not state how many units are affected, and it does not list a UPC.

What Triggered the Recall

The reason for the recall is a performance issue tied to Lot B38062. Health Canada describes the issue as one that may lead to a negative analytical bias and to calibration-related failures. The notice does not say how the issue was found, and it does not explain the cause.

In laboratory terms, an analytical bias is a systematic tendency for a test to read away from the true value. A negative bias means results may run lower than they should. Calibration is the process that sets a test’s reference points so that results can be read correctly, so a calibration-related failure means that process may not work as intended. Because of this, the manufacturer has chosen to pull the lot rather than leave it in circulation.

The notice calls the removal precautionary. It does not report any injuries, adverse events or patient harm linked to the lot.

Understanding the Type II Classification

Health Canada has assigned this recall to Type II. Under Health Canada’s general recall framework, Type II generally refers to situations where use of, or exposure to, a product may cause temporary or medically reversible health consequences, or where the chance of serious harm is considered remote. The notice itself does not spell out that definition, so readers who need the exact wording should refer to Health Canada’s published guidance.

Who Should Be Concerned

The audience listed on the notice is healthcare. That points to laboratories, hospitals and other facilities that use the HemosIL AcuStar HIT-IgG(PF4-H) test and may hold stock from Lot B38062. The recall is not aimed at consumers shopping at retail stores.

The manufacturer is Instrumentation Laboratory Co., located at 180 Hartwell Road, Bedford, Massachusetts, United States. Health Canada published the notice, and it lists Canada as the affected area. The notice does not name specific provinces, distributors or facilities.

Steps Consumers Should Take

The only action listed by Health Canada in the summary is to contact the manufacturer if you require additional information. The notice does not provide a phone number, email address or a step-by-step return process, so anyone who holds the affected lot should look for the manufacturer’s contact details through their usual supplier channels.

• Check your inventory for HemosIL AcuStar HIT-IgG(PF4-H), catalogue number 0009800127.
• Look for Lot B38062 on the packaging or in your records.
• Contact Instrumentation Laboratory Co. if you require additional information about the recall.

Facilities should follow any instructions they receive directly from the manufacturer or their distributor. The Health Canada notice does not give further handling or disposal directions.

Regulatory Response

Health Canada, through its Medical devices program, published the recall on the Recalls and safety alerts portal. The page lists the recall type as a Health product recall, the audience as Healthcare, and the issue as Medical devices – Performance. The notice was last updated on October 15, 2026.

People who want updates on new and updated recalls can subscribe to email notifications through the Government of Canada recalls site. Anyone with a health or safety concern about a product can also report it through Health Canada’s online reporting page.

What We Know and What We Do Not

This 2026 recall is narrow and specific: one product, one lot and one catalogue number. The notice clearly identifies the risk as a potential negative analytical bias and calibration-related failures, and it classes the recall as Type II. It does not state the number of units affected, the date the issue was first identified, the root cause, or any reports of harm.

Readers should treat Health Canada’s page as the authoritative source and check it for any updates, since recall notices can be revised as more information becomes available.