FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics Inc.: Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
- Recall number
- Z-2470-2020
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-05-15
- Posted
- not on file
- Terminated
- 2022-08-12
- 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
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 2925 units
- 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.
- Lot, serial or model codes
- Serial numbers A001 through M5295
- 510(k) numbers
- ["K970227"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1000122204
- Firm city
- Flanders
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28