Siemens FlexLab Automation Modules Recalled for Potential Safety Concerns
Siemens Healthcare Diagnostics is voluntarily recalling 448 FlexLab Automation Modules. The recall was initiated by the firm and is classified as Class II.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any injuries, illnesses, or fatalities, and the specific hazard is not detailed, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is voluntarily recalling 448 units of FlexLab Automation Modules. The affected products include Refrigerated Storage Modules (RSM), Centrifuges (CM), and i2000SR units. The recall was initiated by the firm on September 29, 2016, and was classified as Class II by the FDA.
The source text does not specify the exact reason for the recall or the specific hazard associated with these devices. The products were distributed nationwide in the United States and to numerous international locations, including Australia, Canada, Germany, and the United Kingdom.
The recall status is currently terminated. Consumers and healthcare facilities with these specific modules should contact Siemens Healthcare Diagnostics for further instructions on how to proceed with the recall.
The recalled product
- Product
- FlexLab Automation Modules
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 448
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.
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