Mechatronics USA: 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) in

Hazard

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.

Details from the source

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: Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands. Quantity: 10752 units Lot/code info: UDI: (01)08719189137125(17)240222(10)QCAB6AAA28 Lot Number/Exp. Date: QCAB6AAA28 24-02-2022

UPC codes

08719189137125

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.