Siemens Healthcare Recalls EMIT II Plus 6-Acetyl Morphine Reagents
Siemens Healthcare Diagnostics is recalling EMIT II Plus 6-Acetyl Morphine reagents due to incorrect calibrator levels listed in the calibration steps.
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, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Syva EMIT II Plus 6-Acetyl Morphine reagent (Catalog # 9R039UL / SMN# 10470440). The recall was initiated because the product documentation lists an incorrect calibrator level in the qualitative calibration steps.
The affected product is distributed in Pennsylvania, Massachusetts, Texas, Maine, Utah, Florida, Kansas, New Hampshire, Kentucky, and foreign markets. All lots of the product are included in this recall.
The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Users of the product should contact Siemens Healthcare Diagnostics for further instructions regarding the recall.
The recalled product
- Product
- Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
- 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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