ADVIA Chemistry Triglyceride Concentrated (TRIG_c) Reagent. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-01103-1

Class II

2016-08-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01103-1

Siemens healthcare diagnostics has confirmed the advia chemistry triglyceride concentrated reagent (trig_c) does not meet instructions for use (ifu) linearity claim at the upper limit of the assay range as it approaches the end of its shelf life. internal testing indicates that a patient bias (-7% to -12%) may be seen at concentration levels from 6.22 to 6.78 mmol/l. linearity is reduced by approximately 50% at triglyceride concentrations approaching the upper end of the extended range of 12.43 mmol/l.Quality control (qc) material may not detect this issue depending on the triglyceride concentrations in the qc material.Siemens internal testing has confirmed all other in date lots are currently meeting linearity ifu claims. however, as a precaution, until root cause is determined, a short term mitigation of reducing the expiration date to 6 months for all lots of advia chemistry systems triglyceride concentrated has been implemented.

Siemens is advising users to discontinue use and discard any remaining stock of lots 365096 and 379597. Discontinue use and discard remaining lots once they reach the revised shelf life. Customers will need to manually monitor the revised expiration dates for the impacted lots. A review of previously generated results is at the discretion on the Laboratory Director.