FDA-Device2023-06-14Class III
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
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.
Sold states
Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.
Affected count
9306 units
Manufactured in
20 Altieri Way Unit 4, Warwick, RI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2023Don't want to check this manually?
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