Roche URISYS 2400 Urine Analyzer Recalled for Sharp Edge Injury Risk
Roche is recalling URISYS 2400 Urine Analyzers because a sharp edge on the sample rack tray caused four reported injuries.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves four reported injuries, meeting the rubric criteria for a Severe rating (Class II with injury reports).
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the URISYS 2400 Urine Analyzer, an automated urinalysis system. The recall involves 9,014 units distributed nationwide in the United States.
The recall was initiated after Roche received four reports of injury caused by the sharp edge of the center guide rail on the analyzer's sample rack tray. The company has revised the cleaning procedure for the sample rack tray to clarify the cleaning process and address the hazard.
Users of the URISYS 2400 should contact Roche Diagnostics Operations, Inc. for instructions on how to proceed with the recall and the updated cleaning procedures.
The recalled product
- Product
- URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 9,014
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)
- Not applicable
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Roche Diagnostics Operations, 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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