FDAApril 14, 2023device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
mechatronics
UPCs
08719189137118
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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