Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Summary
The FDA issued a Class III for Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 by Siemens Healthcare Diagnostics, Inc.. Reason: out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results we.
Details
Source
Device Recall
External ID
Z-2881-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Lot/Code Info: UDI-DI 00842768014321 Lot U2
Quantity Affected: 494 US; 114 OUS
Reason for Recall
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
Distribution
Worldwide - US Nationwide distribution in the states CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and Northern Mariana Islands part of USA and the countries of Canada, South Africa, Brazil, Chile, Colombia.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-26
Company
East Walpole, MA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 165 FDA actions in our database, including 142 recalls and 23 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 165 FDA actions in our database, including 142 recalls and 23 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2881-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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