Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Medtest Holdings
10 recalls • • Categories: Diagnostic Equipment, Other Medical Devices, Infusion Pumps
Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.
Class I - Dangerous
Incorrect control range in product labeling
Linear performance information in product insert does not match that listed in the approved premarket notification
Decrease reactivity of R 1 component.
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.
Class I - Dangerous
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
Class I - Dangerous
The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1. Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.