| Class 2 Device Recall ADVIA Chemistry (Syva Onboard) Theophylline_2 reagent | |
Date Initiated by Firm | June 17, 2016 |
Date Posted | July 28, 2016 |
Recall Status1 |
Terminated 3 on March 15, 2017 |
Recall Number | Z-2298-2016 |
Recall Event ID |
74524 |
510(K)Number | K913123 |
Product Classification |
Enzyme immunoassay, theophylline - Product Code KLS
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Product | Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma. |
Code Information |
Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 Syva¿ EMIT¿ 2000 Theophylline - kit lot G3 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr Ms 514 PO BOX 6101 Newark DE 19702-2466
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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 | 1,004 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 |
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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.
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510(K) Database | 510(K)s with Product Code = KLS
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