Siemens StreamLAB Analytical Workcell Recalled for Trip and Fall Hazard
Siemens is recalling 317 StreamLAB Analytical Workcells because protruding pins on the Input/Output Module have contributed to trip and fall incidents.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where trip and fall incidents have been reported, but no specific injuries or fatalities are detailed in the source text, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 317 units of the Siemens StreamLAB(R) Analytical Workcell, catalog number 746002.901. This device is designed to automate sample handling and processing in clinical laboratories. The recall covers all serial numbers of the affected model.
The recall was initiated after the firm received reports from customers that small pins at the bottom of the center door panel of the Input/Output Module contributed to trip and fall incidents. These pins protrude approximately 5/8 inch (16 mm) from the device. The affected units were distributed nationwide to facilities in 36 states, including Alabama, Arizona, California, Florida, New York, and Texas.
Customers are advised to be aware of the two protruding pins when working in the area of the Input/Output Module and to use caution to prevent injury.
The recalled product
- Product
- Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 317
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 serial numbers
Distribution
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