Siemens Healthcare Diagnostics, Inc. recalls Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog…
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.
Affected product
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Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No.7C219ULUDI-DI 00842768014321
What the firm is doing
On June 26, 2026, the firm began notifying customers via Urgent Medical Device Correction letters. Customers were informed of the issue and provided with revised Safety Data Sheets (SDS) specific to the impacted lots for handling and disposal information.
DistributionShow detailsHide
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.
Use of the product is not likely to cause adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2881-2026
- FDA 510(k) clearance · K821743The device's official FDA premarket clearance record
- FDA device classification · LFGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 862.3910The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Siemens Healthcare Diagnostics, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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