FDA recall Z-2470-2020

Siemens Healthcare Diagnostics Inc. · Class II · 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.

Reason for recall

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

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, 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.

Key facts

Status
Terminated
Initiation date
2020-05-15
Report date
2020-07-08
Termination date
2022-08-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Flanders, NJ, United States

Primary source

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