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U.S. Department of Health and Human Services

Class 2 Device Recall Syva Emit 2000 Theophylline Assay

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  Class 2 Device Recall Syva Emit 2000 Theophylline Assay see related information
Date Initiated by Firm November 27, 2017
Create Date May 25, 2018
Recall Status1 Terminated 3 on April 19, 2019
Recall Number Z-1946-2018
Recall Event ID 79413
510(K)Number K913123  
Product Classification Enzyme immunoassay, theophylline - Product Code KLS
Product Syva¿ EMIT¿ 2000 Theophylline

Product Usage:
The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
Code Information Catalog # 4P019UL /SMN#10445324 kit lot J1 (UDI# 00842768001024J120190414)
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		 Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient samples.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent an Urgent Medical Device Recall letter dated November 27, 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of affected product, review inventory to determine replacement needs, complete and return Field Correction Effectiveness Check list. For questions contact Siemens Customer Care Center or your local Siemens technical support representative.
Distribution US Nationwide 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 = KLS and Original Applicant = SYVA CO.
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