Z-1316-2014Class II

IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments...

Name: Z-1316-2014 IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments...
Creator: Siemens Medical Solutions Diagnostics
Published: 2014-02-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-02-03 / Terminated / root cause: design

FDA source

Siemens Medical Solutions Diagnostics began a recall of IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These... on 2014-02-03. FDA classified it as Class II and gives the reason as "There is a potential for incorrect results to be reported from processing of a sample tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1316-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-03
Posted: 2014-04-02
Terminated: 2016-06-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: There is a potential for incorrect results to be reported from processing of a sample tube.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an Urgent Medical Device Correction letter dated February 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers was told how to correct the issue if it has occurred, and how to prevent the issue from occurring. The completed form should be faxed to (302) 631-7597. Any questions can be directed to Siemens Technical Support Representative. Siemens plans to implement a correction at a later time.
Quantity in commerce: 1006 units
Distribution: Nationwide and Foreign Distribution.
Product codes and lots: IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1316-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1316-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)