Roche Modular Pre Analytics EVO/Plus Recall for Sharp Edge Injury Risk
Roche is recalling Modular Pre Analytics EVO/Plus systems 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, which aligns with the rubric criteria for a Severe rating (FDA Class II with injury reports).
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 units of the Modular Pre Analytics (EVO/Plus) system. The recall is due to a sharp edge on the center guide rail of the analyzer's sample rack tray, which has resulted in four reported injuries.
The affected product is a computer-controlled stand-online system used for decapping, aliquoting, and sorting primary tubes, as well as producing and sorting bar-coded secondary tubes. The system operates with an online connection to a host computer.
The recall covers units distributed nationwide in the United States. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. Users of these systems should contact Roche Diagnostics for further instructions on the recall and revised procedures.
The recalled product
- Product
- Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar coded secondary tubes.. The system operates with an online connection to the hos
- 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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