Health Products

GSP® Neonatal GALT kit

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: GSP® Neonatal GALT kit
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
GSP® Neonatal GALT kit10765033013303-001U
GSP® Neonatal GALT kit10766420013303-001U
GSP® Neonatal GALT kit10769355013303-001U
GSP® Neonatal GALT kit10767873013303-001U

Issue

The recall is initiated to inform customers of an observed reduced on-board stability of GSP GALT assay (3303-001U), which may increase the likelihood of delayed reporting of patient results as a result of increased run-QC failures. Please see Medical device recall letter for customer instructions.

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