The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1141-2017·Announced 2017-02-15

Siemens Dimension Vista Ammonia Flex Reagent Cartridge Recall

Siemens is recalling specific lots of Dimension Vista Ammonia Flex reagent cartridges because they may not meet the 60-day calibration interval claim, potentially resulting in abnormal assay results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to potential assay errors due to reagent instability, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 8,032 units of Dimension Vista Ammonia Flex reagent cartridges (K3119). The affected lots are 16187BE, 16225BB, and 16265AB. These products were distributed nationwide in the United States and internationally to numerous countries, including Argentina, Australia, Brazil, Canada, China, France, Germany, India, Japan, and the United Kingdom.

The recall was initiated because the reagent cartridges do not meet the 60-day calibration interval claim due to reagent instability. This instability may cause the clinical chemistry system to display an 'Abnormal Assay' result. The Dimension Vista Ammonia Flex reagent cartridge is an in vitro diagnostic test used for the quantitative measurement of ammonia in human plasma, which is utilized in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis, and Reye's syndrome.

Healthcare facilities and laboratories that have these specific lots in inventory should stop using them and contact Siemens Healthcare Diagnostics for instructions on return or replacement. Patients who have had ammonia tests performed using these specific lots should consult their healthcare provider to discuss the potential impact on their diagnostic results.

The recalled product

Product
Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment…
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic Reagent
Hazard
Affected units
8,032

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 (2)

  • lots 16187BE
  • 16225BB and 16265AB

Distribution

Distributed nationwide across the United States.

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.

See all 2 products in this recall →

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