directCHECK™ Whole Blood Control
Brand(s)
Last updated
Summary
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
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| directCHECK™ Whole Blood Control | A6DLA001 | DCGLR‑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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
| Bionostics Inc |
| 7 Jackson Road, Devens, Massachusetts, United States, 01434 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82075
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