Quality & complianceOfficial

Health Canada flags Helena Plateletworks collagen kit lot over falsely low aggregation results

🇨🇦 Health Canada · Wed 04 Nov 2026

A Type II recall covers one lot of Plateletworks Collagen Kit after internal testing found many tubes aggregated poorly, risking false suggestions of abnormal platelet function.

Health Canada has published a recall of a Helena Laboratories Plateletworks Collagen Kit, citing a performance problem with the collagen tubes in one lot. The recall date is 21 October 2026 and the notice was posted on 4 November 2026 under identification number RA-82907.

The affected product is catalogue number 5852, lot 3-26 (3-26-552076). The regulator says tubes from this lot show poor aggregation. In internal testing with normal donor blood, five of eight tubes were definitively abnormal, one was equivocal and two were normal.

The notice says the effect differs from tube to tube. As a result, a kit from this lot that passes in-house quality control may still contain affected tubes. A faulty tube may give a falsely low percent aggregation with collagen, which could point to abnormal platelet function when function is in fact normal.

Health Canada notes that the procedure insert already advises repeating any questionable result, in duplicate, and interpreting results in light of the patient's clinical history and condition. Users needing more information are told to contact the manufacturer, which is based in Beaumont, Texas. The recall is classed as Type II and is aimed at healthcare audiences.

As general context, a Type II recall in Canada generally covers products that may cause temporary or medically reversible health effects, or where serious harm is considered unlikely.

What it means for your team

  • Laboratories using Plateletworks collagen kits should check whether they hold lot 3-26 (3-26-552076), catalogue number 5852.
  • Passing in-house quality control does not rule out affected tubes in this lot, so QC alone may not be a sufficient safeguard.
  • Quality teams may wish to review recent collagen aggregation results from this lot, applying the repeat-in-duplicate guidance in the procedure insert.
  • Manufacturers and distributors should note the regulator's emphasis on tube-to-tube variability when assessing lot-release testing.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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