Recall Z-2469-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics Inc.
Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
| Date | May 15, 2020 |
| Status | Terminated |
| Reason | Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard |
| Root cause | Nonconforming Material/Component |
| Action | Siemens issued an Urgent Medical Device Correction (UMDC IMI20-01.A.US) to US customers via FedEx on May 15, 2020. Urgent Field Safety Notice (UFSN IMI20-01.A.OUS) was electronically issued to all OUS Siemens sites with affected customers, for distribution, as well as regional reporting to their respective local competent authority on May 15, 2020. The field action letters explain the issue, health risk and and inform customers of actions to take: Siemens Customer Service Engineers shall be visiting customer sites to replace Waste Bottle Flex Tubing Assemblies. Customers are requested to re |
| Quantity | 1555 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of AE, AO, AR, AT, AU, AZ, BA, BD, BE, BG, BH, BO, BR, BS, BY, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GP, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, KZ, LB, LT, LU, LV, LY, ME, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER Dpc Cirrus, Apr 8, 1997 |