—#181652

Product

Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K970227
Affected lot / code info: Serial numbers B0058 through S5970

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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 return the Effectiveness Check Form, in the UMDC/UFSN via fax or email.

Recalling firm

Firm: Siemens Healthcare Diagnostics Inc.
Address: 62 Flanders-Bartley Rd., Flanders, New Jersey 07836-4715

Distribution

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.

Timeline

Recall initiated: 2020-05-15
Terminated: 2022-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181652. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.