Device Recall Optilite Freelite Lambda Free Kit 의 리콜

Recall

76048

Class 2

Z-1043-2017

2016-07-05

2017-01-18

Terminated

United States

2017-07-03

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152050

Batch numbers listed are reporting lambda free light chain results >114mg/l that are on average 33% lower than other optilite lambda freelite batches. therefore users moving to this batch will see results >114mg/l giving lower results and conversely when switching to the next batch results will be seen to shift upwards.

On 07/05/16 notification letters were sent to customers. The Binding Site Group requests the following: - Immediately Quarantine & Dispose of any LK018.OPT lot 405566 kits within stock; - Remove any affected lots from the Optilite instrument; - Patients with Lambda Freelite results >114mg/L should be reviewed in consultation with clinicians, alongside other clinical findings and retested where applicable; - Notify local Binding Site representative to request replacement kits; - Return completed E-Back Form to local Binding Site Representative; The firm recommended that the notice be circulated to those within the organization who need to be aware.