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.
FDA Recall Z-2299-2016 · Posted 2016-07-28
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeKLS
Date Initiated2016-06-17
Date Terminated2017-03-15
Product Quantity658 units
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
Firm 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.
Root Cause
Process control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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