Siemens Healthcare Diagnostics, Inc. — Class III: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No
Siemens Healthcare Diagnostics, Inc. initiated a Class III recall for Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls (Lot U2) due to an out-of-specification concentration of sodium azide. The FDA notes that while assay results remain unaffected, the error involves a chemical formulation deviation.
Siemens Healthcare Diagnostics, clinical laboratory technicians using Syva Emit tox assays, and quality control departments managing diagnostic calibrator inventories.
Although the health risk to laboratory personnel is categorized as low and no serious harm is anticipated, this represents a failure in manufacturing or formulation controls to meet pre-defined specifications. For regulatory professionals, it highlights the importance of maintaining tight tolerances for preservative concentrations, even when the primary diagnostic function of the device remains intact. The Class III designation suggests the agency views the risk of adverse health consequences as remote.
Ensure affected Lot U2 is identified and sequestered according to standard recall procedures. Review safety data sheets (SDS) regarding sodium azide handling for lab personnel to mitigate potential skin or eye irritation risks. Verify that incoming raw material or formulation controls are sufficient to maintain sodium azide within established specifications.
Class III. Reason: 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.. Product: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL. Firm: Siemens Healthcare Diagnostics, Inc. (East Walpole MA United States). Status: Ongoing.
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