Roche cobas 8000 Analyzer Filters Recalled for Potential Performance Issues
Roche Diagnostics is recalling cobas 8000 analyzer filters that may cause discrepant results, alarms, or foam under certain conditions.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported. The hazard is limited to potential performance issues (discrepant results, alarms) rather than direct physical harm, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 149 units of cobas 8000 analyzer series filters (Mat. No 03149773001) distributed nationwide in the United States. The recall is due to a defect where loose ProCell/CleanCell aspiration tube filters may cause consecutive discrepant results, sipper alarms, foam on reservoirs, and system reagent alarms under certain conditions.
These filters are components of a fully automated immunoassay analyzer intended for the in-vitro quantitative and qualitative determination of analytes in body fluids. The affected units are identified by specific lot codes listed in the recall documentation. No illnesses or injuries have been reported in connection with this recall.
Users of the cobas 8000 analyzer series should check their inventory for the affected lot codes and stop using the recalled filters. Users should contact Roche Diagnostics for further instructions on how to proceed with the recall.
The recalled product
- Product
- cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body…
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 149
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 (20)
- 1125-07
- 1017-06
- 1021-03
- 1021-05
- 1016-05
- 1017-01
- 1124-05
- 1124-06
- 1128-02
- 1132-03
- 1132-04
- 1131-08
- 1132-01
- 1132-02
- 1128-05
- 1128-06
- 2374-11
- 1132-05
- 1132-10
- 1137-02
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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