Roche RSD 800A Aliquoting System Recalled Due to Sharp Edge Injury Reports
Roche is recalling 9,014 RSD 800A Aliquoting System calculator/data processing modules because four reports of injury were received from the sharp edge of the sample rack tray.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Severe because the source text explicitly reports four instances of injury caused by the product, which aligns with the rubric criterion for 'significant injury reports.'
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 units of the RSD 800A Aliquoting System calculator/data processing module. These modules are used in the Roche/Hitachi MODULAR Analytics System, a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations.
The recall was initiated after Roche received four reports of injury caused by the sharp edge of the center guide rail of an analyzer's sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
The affected products were distributed nationwide in the United States. Healthcare facilities and laboratories using this equipment should contact Roche Diagnostics Operations, Inc. for instructions on how to proceed with the recall and the revised cleaning procedures.
The recalled product
- Product
- RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and…
- 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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