Syva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
Siemens Healthcare Diagnostics is recalling Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1 due to out-of-specification sodium azide concentration.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, and the source states the health risk is low with no serious harm anticipated.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine (SMN 10445370, Catalog No 6N319UL, Lot U1) because the sodium azide concentration is out of specification.
While the assay results were not impacted, the sodium azide concentration poses a low health risk to lab technicians. Exposure is limited by small volumes and a 0.2% post-reconstitution concentration. The potential worst outcome is mild skin or eye irritation, with no serious harm anticipated.
This recall affects 8 units in the US and 44 units overseas, with distribution in the US states of CA and VA, and in Japan.
The recalled product
- Product
- Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00842768001406 Lot U1
Distribution
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