Recall Z-2361-2020 ยท JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Abaxis Inc
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
| Date | Dec 11, 2019 |
| Status | Terminated |
| Reason | Incorrect reference ranges of analytes. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 15 |
| Distribution | All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934592 | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR Abaxis, Inc., Apr 6, 1994 |