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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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  Class 2 Device Recall Siemens see related information
Date Initiated by Firm February 03, 2014
Date Posted April 02, 2014
Recall Status1 Terminated 3 on June 30, 2016
Recall Number Z-1316-2014
Recall Event ID 67586
510(K)Number K970227  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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
Code Information IMMULITE 2000:  10380062, 10380061,10380079, 10380065, 10360210, 10283632  IMMULITE 2000XPi: P010053/S007;   10373214  VersaCell:   10380063, 10389945, 10380064, 10287115, 10793839
Recalling Firm/
Manufacturer		 Siemens Medical Solutions Diagnostics
62 Flanders-Bartley Rd
Flanders NJ 07836-4715
For Additional Information Contact
973-927-2828
Manufacturer Reason
for Recall		 There is a potential for incorrect results to be reported from processing of a sample tube.
FDA Determined
Cause 2		 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.
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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