Mechatronics USA recalls RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor th…

Recall date

April 14, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1695-2023

FDA classification

Class III

Brand / firm

Mechatronics USA

Sold / distributed

Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.

Why it was recalled

QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578