Siemens IMMULITE 2000 XPi Analyzer Recalled for Tubing Crack Risk
Siemens Healthcare Diagnostics Inc. is recalling 2,925 IMMULITE 2000 XPi Immunoassay Systems because flexible tubing can crack, causing liquid waste leaks and slip hazards.
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 (slip and fall hazard) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling 2,925 units of the Siemens IMMULITE 2000 XPi Immunoassay System, an in vitro chemistry analyzer intended for professional use in a laboratory environment. The affected units have serial numbers ranging from A001 through M5295. The recall covers units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because the flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance. This cracking can potentially cause liquid waste to leak onto the floor, creating a slip and fall hazard for personnel in the laboratory.
No specific instructions for end-users are provided in the source text, but the product is intended for professional laboratory use. Facilities using these analyzers should be aware of the potential for tubing failure and associated slip hazards during maintenance.
The recalled product
- Product
- Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Hazard
- Affected units
- 2,925
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)
- Serial numbers A001 through M5295
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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