ADVIA Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analys
FDA device recall Z-2299-2016 · posted 2016-07-28 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- KLS
- Quantity affected
- 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
- Date initiated
- 2016-06-17
- Date posted
- 2016-07-28
- Date terminated
- 2017-03-15
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS (K913123) | Syva Co. | 1991-09-19 |