Recalls / —
—#147834
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.
- FDA product code
- KLS — Enzyme Immunoassay, Theophylline
- Device class
- Class 2
- Medical specialty
- Clinical Toxicology
- 510(k) numbers
- K913123
- Affected lot / code info
- ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent - SMN# 10377503, Lot # 334018
Why it was recalled
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
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466
Distribution
- 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
Timeline
- Recall initiated
- 2016-06-17
- Posted by FDA
- 2016-07-28
- Terminated
- 2017-03-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #147834. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.