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FDA (Device enforcement)Recalled 2023-04-14class iii

Mechatronics USA: RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rat

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: 9306 units Lot/code info: UDI-DI: (01)08719189137118(17)240222(10)QCAB6AN505 Lot Number/Exp Date: QCAB6AN505 24-02-2022

UPC codes

08719189137118

Source

Official record: FDA (Device enforcement)

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

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