directCHECK™ Whole Blood Control

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

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.

directCHECK™ Whole Blood Control

RA-82075