Recall Monitor
Health Products

directCHECK™ Whole Blood Control

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Haematology
Product: directCHECK™ Whole Blood Control
Issue: Medical devices - Labelling and packaging
What to do: Customer notification letter to be sent. Instructions to be provided on disposal of affected units
Audience: Healthcare
Recall class: Type II
Get told about the next health product recall.

We email or text you when Canada issues a recall that matches what you watch: a brand, a product, an allergen. Most never make the news.

Get health product recall alerts

CA$3.99/mo · cancel anytime

Products

Affected productsLot or serial numberModel or catalogue number
directCHECK™ Whole Blood ControlA6DLA001DCGLR‑2

Issue

Instances of consistently elevated results were identified when using directCHECK™ Whole Blood Control DCGLR‑2, lot A6DLA001. A process error led to testing the lot on the wrong instrument platform, which resulted in the creation and release of incorrect Quality Control (QC) ranges on the performance range card distributed with this lot.

Get told about the next health product recall.
Get health product recall alerts

CA$3.99/mo · cancel anytime