Syva EMIT 2000 Theophylline - Catalog # 4P019UL… recallZ-2298-2016 · Siemens Healthcare Diagnostics, Inc. · initiated Jun 17, 2016
Class II Terminated All recalls posted in July 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2298-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 17, 2016
- Posted by the FDA
- Jul 28, 2016
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1,004 units
- Product code
- KLS
- FDA submissions
- K913123
- 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
Product description
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 (models, lots, serial numbers)
Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 Syva¿ EMIT¿ 2000 Theophylline - kit lot G3
Other devices under the same FDA submission
1 device cleared under K913123 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Syva® Emit® 2000 Theophylline Assay 10445324Siemens Healthcare Diagnostics Inc. · ENZYME IMMUNOASSAY, THEOPHYLLINE1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 74524).
- Z-2299-2016 · TerminatedADVIA 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 Che…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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