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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 June 17, 2016
Date Posted July 28, 2016
Recall Status1 Terminated 3 on March 15, 2017
Recall Number Z-2299-2016
Recall Event ID 74524
510(K)Number K913123  
Product Classification Enzyme immunoassay, theophylline - Product Code KLS
Product ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems.
Copies of IFUs included in submission.
Code Information ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent - SMN# 10377503, Lot # 334018
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Care Center
312-275-7795
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples
FDA Determined
Cause 2		 Process control
Action Siemens Healthcare Diagnostics mailed a letter to customers on June 17, 2016, asking that they discontinue use of and discard the affected kit lots identified in the recall notification letter. Customers were also asked to complete and return the Field Correction Effectiveness Check/Product Replacement Form that was mailed with the Recall Notification Letter.
Quantity in Commerce 658 units
Distribution Distributed to: CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA
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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