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Directcheck™ whole blood control

Official notice

14 May 2026

Last checked

14 May 2026

Medium riskHealth Canada
Watch Bionostics

An official Health Canada notice concerns Directcheck™ whole blood control. 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. Published 2026-05-14.

What to do now

Customer notification letter to be sent. Instructions to be provided on disposal of affected units

Recall number

82075

Official notice

2026-05-14

The hazard

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.

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Lots

A6DLA001

Skus

DCGLR‑2

Other

RA RA-82075

Model Numbers

DCGLR‑2

Recall Numbers

82075

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Affected products

Product 1

Lot or serial number - A6DLA001, Model or catalogue number - DCGLR‑2

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Bionostics

Manufacturer

Not provided

Phone

Not provided

Brand: Bionostics.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

82075

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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