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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens IMMULITE 2000 and IMMULITE 2000XPi

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  Class 2 Device Recall Siemens IMMULITE 2000 and IMMULITE 2000XPi see related information
Date Initiated by Firm March 05, 2015
Date Posted May 23, 2015
Recall Status1 Terminated 3 on January 16, 2018
Recall Number Z-1658-2015
Recall Event ID 71022
510(K)Number K970227  
PMA Number P010053S007 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product 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.
Code Information (Water Bottle) - Product Code #10380062; Catalog #10291586
Recalling Firm/
Manufacturer		 Siemens Medical Solutions Diagnostics
62 Flanders-Bartley Rd
Flanders NJ 07836-4715
For Additional Information Contact Mr. Michael Metz
914-524-2223
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.
Quantity in Commerce 186 bottles
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = DPC CIRRUS
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