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Mechatronics USA FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to mClass IIIApr 14, 2023QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 L
RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor tClass IIIApr 14, 2023QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 L

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