Helena Laboratories Test Kit Recalled for False Results: Health Canada

Health Canada says Helena Laboratories has recalled one lot of its Plateletworks Collagen Kit because the collagen tubes can aggregate poorly and produce falsely low platelet readings. Labs and clinics holding lot 3-26 (3-26-552076) should check their stock and contact the manufacturer for further information.

Recalled Products at a Glance

The notice covers a single product from a single lot. It is aimed at healthcare audiences, not the general public.

• Product: Plateletworks Collagen Kit
• Brand: Helena Laboratories, Corp
• Model or catalogue number: 5852
• Lot or serial number: 3-26 (3-26-552076)
• Category: Medical devices, haematology
• Recall class: Type II
• Recall number: RA-82907

The notice gives no UPC and does not say how many kits are affected.

What Triggered the Recall

The problem is poor aggregation with collagen in tubes from this lot. Health Canada reports that internal testing used normal donor blood. Of 8 tubes tested, 5 were definitively abnormal, 1 was equivocal and 2 came back normal.

Results vary from tube to tube. A kit from this lot can therefore pass the in-house quality control check and still contain affected tubes.

An affected tube may return a falsely low percent aggregation with collagen. That reading could suggest abnormal platelet function when the patient’s platelets are working normally.

Who Should Be Concerned

Health Canada lists the audience as healthcare. That means laboratories and clinical staff who use the Plateletworks Collagen Kit, along with the patients whose platelet function tests are run with it.

The notice does not name provinces, distributors or a quantity shipped to Canada. The manufacturer is based in Beaumont, Texas, United States. The recall date on the notice is 2026-10-21, and Health Canada published it on 2026-11-04.

What Consumers Need to Do Now

Health Canada’s instruction is short: contact the manufacturer if you need additional information. The notice does not describe a return, replacement or refund process. Facilities that use the kit can still take practical steps based on what the notice says.

• Check kit stock for catalogue number 5852 and lot 3-26 (3-26-552076).
• Contact Helena Laboratories, Corp for more information. The notice gives the company’s address as 1530 Lindbergh Drive, Beaumont, Texas, United States, 77707, and no phone number or email.
• Repeat any questionable collagen result, and run it in duplicate, as the procedure insert already directs.
• Interpret results in light of the patient’s clinical history and condition.

Frequently Asked Questions

Can a kit from this lot be trusted if it passed quality control?

Not necessarily. Health Canada says the effect differs from tube to tube, so a kit that passes in-house quality control may still hold affected tubes.

What could go wrong with a test result?

A tube may show a falsely low percent aggregation with collagen. That could point to abnormal platelet function in a patient whose function is normal.

Is there a phone number or website to call?

The notice does not specify one. It lists only the manufacturer’s mailing address and tells users to contact the manufacturer for more information.

From the Agency

Health Canada says the recall was issued because of poor aggregation with collagen tubes from the affected lot. It also points users to the procedure insert, which says any questionable result should be repeated in duplicate and read alongside the patient’s clinical history and condition.