Siemens Medical Solutions Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-1658-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.

Product Classification:

Class II

Date Initiated: March 5, 2015

Date Posted: June 3, 2015

Recall Number: Z-1658-2015

Event ID: 71022

Reason for Recall:

The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.

Status: Terminated

Product Quantity: 186 bottles

Code Information:

(Water Bottle) - Product Code #10380062; Catalog #10291586

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated