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U.S. Department of Health and Human Services

Class 2 Device Recall Emit 2000 Phenobarbital Assay and Syva Emit 2000

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  Class 2 Device Recall Emit 2000 Phenobarbital Assay and Syva Emit 2000 see related information
Date Initiated by Firm August 30, 2013
Date Posted November 07, 2013
Recall Status1 Terminated 3 on August 27, 2014
Recall Number Z-0181-2014
Recall Event ID 66267
510(K)Number K011528  K913190  
Product Classification Enzyme immunoassay, phenobarbital - Product Code DLZ
Product Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Code Information Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380.
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Siemens Diagnostics Customer Serv.
800-441-9250
Manufacturer Reason
for Recall
Imprecision with certain lots
FDA Determined
Cause 2
Nonconforming Material/Component
Action Siemens sent an Urgent Medical Device Recall letter dated August 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product. Siemens will replace unused affected product at no charge. For replacements customers were instructed to incude this information on the Effectiveness Check form included with the letter. The Effectiveness Check form must be returned even if no replacement reagents are needed. The recall letter was to be retained with customers laboratory records and forwarded to those who may have received this product. Customers with questions were instructed to contact Siemens Technical Solutions or their Siemens technical support representative. For questions regarding this recall call 800-441-9250.
Quantity in Commerce 4963
Distribution Worldwide Distribution - USA (nationwide) and Mexico.
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 = DLZ and Original Applicant = SYVA CO.
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