Siemens Syva EMIT II Plus 6-Acetylmorphine Recalled for Calibration Error
Siemens Healthcare Diagnostics is recalling Syva EMIT II Plus 6-Acetylmorphine reagents because the calibrator level listed in the qualitative calibration steps is incorrect.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation error regarding calibration steps, fitting the criteria for cosmetic or documentation issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Syva EMIT II Plus 6-Acetylmorphine reagent, catalog number 9R129UL (SMN# 10481483), for 1000 mL volumes. The recall affects all lots of the product.
The recall was initiated because the calibrator level listed in the qualitative calibration steps is incorrect. This documentation error could potentially affect the accuracy of the test results.
The product was distributed in Pennsylvania, Massachusetts, Texas, Maine, Utah, Florida, Kansas, New Hampshire, Kentucky, and foreign locations. Users of this product should contact Siemens Healthcare Diagnostics for further instructions on how to proceed.
The recalled product
- Product
- Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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)
- All lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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