Syva EMIT 2000 Theophylline recallZ-1946-2018 · Siemens Healthcare Diagnostics, Inc. · initiated Nov 27, 2017
Terminated
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
Lot J1 of the Syva EMIT 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient samples.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Siemens sent an Urgent Medical Device Recall letter dated November 27, 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of affected product, review inventory to determine replacement needs, complete and return Field Correction Effectiveness Check list. For questions contact Siemens Customer Care Center or your local Siemens technical support representative.
Recall details
- Recall number
- Z-1946-2018
- Status
- Terminated
- Initiated by the company
- Nov 27, 2017
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product code
- KLS
- FDA submissions
- K913123
- Distribution
- US Nationwide Distribution
Product description
Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay 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)
Catalog # 4P019UL /SMN#10445324 kit lot J1 (UDI# 00842768001024J120190414)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Syva® Emit® 2000 Theophylline Assay 10445324Siemens Healthcare Diagnostics Inc. · ENZYME IMMUNOASSAY, THEOPHYLLINE1 recall0 reports
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 16, 2026. Text above is shown as published by the FDA.
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