Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

Incorrect reference ranges of analytes.

On January 9, 2020, the firm sent an "Urgent Medical Device Recall' to their customers, regarding the chemistry analyzer containing software versions software versions 2.1.55/3.1.3. 5. This software failure may cause the product to display the incorrect reference ranges for certain analytes when gender selection is not set on the device. Erroneous reference values may result in an incorrect diagnosis or treatment plan.The firm informed customers to immediately stop using the devices and return it to the firm. On January 21, 2020, the firm instructed their customers to check the enclosed list of affected analytes and their correct reference range values and informed them that the erroneous reference values may result in an incorrect diagnosis or treatment plan. The affected products are shipped between 11/29/19 and 12/3/19, as either a unit on loan or as a repair/service of unit. The firm instructed customers to immediately examine their inventory and quarantine the product subject to recall. The firm ceased further distribution or use of the product. The firm instructed to the customers that their Technical Support arranged for the product return to the firm and would provide the repaired or replacement at no cost. The firm provided the Technical Support number as 1-800-822-2947 for customers to contact them.