Z-2470-2020Class II

Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 -

Name: Z-2470-2020 Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 -
Creator: Siemens Healthcare Diagnostics Inc.
Published: 2020-05-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-05-15 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics Inc. began a recall of Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory... on 2020-05-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2470-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-15
Posted: 2020-06-29
Terminated: 2022-08-12
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Serial numbers A001 through M5295

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2470-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2469-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-29
Z-2470-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-29

Product code JJE

K970227Class IImmulite 2000 Automated Immunoassay AnalyzerDpc Cirrus / cleared 1997-04-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)