Agency classClass IIOur severity:Severe FDA (Devices)·Z-0100-2017·Announced 2016-11-02

Roche COBAS INTEGRA 800 Analyzer Recalled Due to Sharp Edge Injury Reports

Roche is recalling COBAS INTEGRA 800 analyzers after four reports of injury caused by 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 FDA Class II and involves reported injuries, meeting the criteria for a Severe rating (Score 4) due to significant injury reports.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling the COBAS INTEGRA 800 /800 CTS Analyzer, a chemistry analyzer used for clinical purposes. 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 of the analyzer's sample rack tray. The company has revised the cleaning procedure for the sample rack tray to clarify the cleaning process.

Healthcare facilities and users of these analyzers should contact Roche Diagnostics Operations, Inc. for further instructions regarding the recall and the revised cleaning procedures.

The recalled product

Product: Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online…
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — Clinical Laboratory Analyzer
Hazard: sharp-edge-injury
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.

See all 17 products in this recall →

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