Device evidence

device-recall:cfres:172651

MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.

Official recall number

Z-1743-2019

Evidence summary

Product code: JSO
Recall status: Terminated
Event initiated: June 08, 2018
Root cause: Nonconforming Material/Component
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1743-2019