Medical device manufacturer, Abbott Laboratories, has issued a field safety notice concerning certain lots of ARCHITECT Intact PTH Assay with list numbers: Reagents (8K25-20, 8K25-25, 8K25-27), Calibrators (8K25-01) and Controls (8K25-10).
The manufacturer has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. The issue may also impact established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT Intact PTH Controls do not detect the shift. All current reagent, calibrator, and control inventory is impacted. Falsely elevated patient results are generated when using the ARCHITECT Intact PTH assay.
The manufacturer advises users of the followings:
For non-Enterobacteriaceae (Quality Control purpose), the MIC shift over the time can be greater than +1 dilution when compared to the MICs initially obtained at the time of the release. For Enterobacteriaceae, the over-estimation of MIC can change the category result of isolates having MIC equal or close to the breakpoint. According to the manufacturer, this performance issue leading to this over-estimation of MIC can be detected using the quality control as recommended in the Etest package insert.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 14 February 2014