Device evidence

device-recall:cfres:114768

The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.

Official recall number

Z-0572-2013

Evidence summary

Product code: CEP
Recall status: Terminated
Event initiated: November 05, 2012
Root cause: Nonconforming Material/Component
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0572-2013