Z-2469-2020 Class II Terminated

Recalled by Siemens Healthcare Diagnostics Inc. — Flanders, NJ

FDA device recall Z-2469-2020 was initiated by Siemens Healthcare Diagnostics Inc. on May 15, 2020 and is designated Class II. 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 The recall status is terminated (terminated August 12, 2022). Affected quantity: 1555 units.

Recall Details

Product Type
Devices
Report Date
July 8, 2020
Initiation Date
May 15, 2020
Termination Date
August 12, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1555 units

Product Description

Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - 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 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.

Code Information

Serial numbers B0058 through S5970