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Mechatronics USA recalls RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to m
Recalled June 14, 2023 · FDA recall Z-1694-2023 · Mechatronics USA
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. · FDA Class III
Units
9306 units
Sold at
Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.
Description
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.
Product
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 Rate (ESR) instruments and procedures. Product Code: A0026577
Manufacturer(s)
Mechatronics USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →