Field Corrective Action Report GLB143074 - Freelite® Human Lambda Free Kit (for use on the SPAPLUS®) : Imprecision at top of calibration curve

 

 

Affected Medical Device : Freelite® Human Lambda Free Kit (for use on the SPAPLUS®)

 

MDA Reference Number : MDA/FCA/2021-P170

 

MDA Registration Number : IVDC8519819-31358

 

Description :

Imprecision may occur as a result of the decreased separation between calibrator 5 (110.45mg/L) and calibrator 6 (173.76mg/L). When the OD values for calibrator 5 exceed those for calibrator 6 the curve fit may show imprecision which extends down to 70mg/L. Curves exhibiting this fit should not be accepted, as stated in Section D.2.2 of the SPAPLUS Reference Guide (FIN012). Calibration curves must only be accepted if Absorbance (Abs) values increase with increasing concentration (Conc.).

 

Local Establishment Contact Detail :

Chong Phui Fun
Trust Diagnostics Sdn. Bhd.
B2-G, Block B, Jalan Selaman 1, Dataran Palma, 68000 Ampang, Selangor, Malaysia.
Tel: +603- 4266 7718
Fax: +603- 4266 8718

 

Email : phuifun.chong@tdxs.com.my