Recall Z-1661-2015— Siemens Medical Solutions Diagnostics

Name: FDA recall Z-1661-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-05

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions Diagnostics, initiated 2015-03-05, terminated 2018-01-16. It names one FDA 510(k) clearance: K970227. Product: Direct Water feed Kit, Catalog#10373222. Reason: 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..

Recalling firm: Siemens Medical Solutions Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2015-03-05
Terminated: 2018-01-16
Firm location: Flanders, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K970227 — IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZERDpc Cirrus·cleared 1997-04-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Direct Water feed Kit, Catalog#10373222

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.