Device product
Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
Z-2470-2020
Product summary
- Event
- Event 85731
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2925 units
- Official record key
device-enforcement:Z-2470-2020
Official wording
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
Code information: Serial numbers A001 through M5295
Distribution pattern: 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, MK, MM, MQ, MT, MU, MX, MY, NL, NO, NZ, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, SY, TH, TN, TR, TT, TW, UA, UY, VE VN, ZA.
Derived failure modes
-
Unknown
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