FDA-Device2020-07-08Class II

Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.

Siemens Healthcare Diagnostics Inc.
Hazard

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

Sold states
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.
Affected count
2925 units
Manufactured in
62 Flanders-Bartley Rd., N/A, Flanders, NJ, United States
Products
Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2470-2020

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