Official recall record

Plateletworks Collagen Kit

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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