Public recall detail

directCHECK™ Whole Blood Control

2026-05-14

medium
Haematology Labelling and packaging
Quick summary

Quick summary: directCHECK™ Whole Blood Control . Reason: Labelling and packaging. Category: Haematology. Date: 2026-05-14.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: directCHECK™ Whole Blood Control . Reason: Labelling and packaging. Category: Haematology. Date: 2026-05-14.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBionostics Inc
ProductdirectCHECK™ Whole Blood Control
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-82075

Affected products

ProductdirectCHECK™ Whole Blood Control
LotA6DLA001
ModelDCGLR‑2
Serial numberA6DLA001
DescriptiondirectCHECK™ Whole Blood Control

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.

What you should do

  • Customer notification letter to be sent. Instructions to be provided on disposal of affected units
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Haematology
CompaniesBionostics Inc 7 Jackson Road, Devens, Massachusetts, United States, 01434
Recall date2026-05-01
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82075
Background{}
CompaniesBionostics Inc 7 Jackson Road, Devens, Massachusetts, United States, 01434
AudiencesHealthcare
Source updated2026-05-14

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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