Recall Z-1077-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
| Date | Mar 30, 2019 (initiated Dec 5, 2018) |
| Status | Open, Classified |
| Reason | When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out. |
| Root cause | Under Investigation by firm |
| Action | On 12/05/18, the firm mailed Urgent Medical Device Recall notices to all consignees. In order to prevent this error from occurring, do not load racks onto the SPU while samples are being processed from the automation line. Either of the following options can be followed to avoid the error: 1) Pause the automation line before loading of any racks onto the SPU. a) To pause the automation line and load racks on the SPU, use the following steps: i) Set the Lab Automation System (LAS) Mode to "Offline" (1) Return to the Main Menu (F9) (2) Select Configure (F8) (3) Select LIS/LAS (F6) (4) Select L |
| Quantity | 2842 |
| Distribution | US: NJ, OH, NY, GA, FL, TN, WI, MI, MS, CA, NC, TX, PA, DC, IN, KY, IL, WA, MN, LA, ND, ID, WV, AK, AL, MA. OUS: Argentina, Australia, Bahrain, Canada, China, Croatia, Czech Republic, Egypt, Germany, Greece, India, Italy, Malaysia, Morocco, Netherlands, Nigeria, Poland, Portugal, Qatar, Saudi Arabi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 Beckman Coulter, Inc., Jan 28, 2003 |