Siemens Medical Solutions Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-1316-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 3, 2014

Date Posted: April 9, 2014

Recall Number: Z-1316-2014

Event ID: 67586

Reason for Recall:

There is a potential for incorrect results to be reported from processing of a sample tube.

Status: Terminated

Product Quantity: 1006 units

Code Information:

IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839

Distribution Pattern:

Nationwide and Foreign Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated