Health Products

CellMek SPS

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Haematology
Product: CellMek SPS
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
CellMek SPSAll lots.C44603

Issue

Issue #1- The instructions for use states that the dead volume for tubes in cassette B is 750ul and cassette E is 1300ul. However, testing shows that the dead volumes are actually 1582ul and 2093ul. Issue # 2- Cassette type E is not rocked prior to aspirating the specimen. Recall start date: August 27, 2025

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