Home / Recalls / Mechatronics USA / Z-1695-2023

Z-1695-2023 Class III Ongoing

Recalled by Mechatronics USA — Warwick, RI

Recall Details

Product Type: Devices
Report Date: June 14, 2023
Initiation Date: April 14, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10752 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

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

Code Information

UDI: (01)08719189137125(17)240222(10)QCAB6AAA28 Lot Number/Exp. Date: QCAB6AAA28 24-02-2022