Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
FDA Recall Z-2881-2026 · Posted 2026-08-04
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeLFG
Date Initiated2026-06-26
Product Quantity494 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.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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