Roche Diagnostics Recalls Sample Probes for Corrosion-Related Liquid Level Detection Issues
Roche Diagnostics is recalling 3,946 sample probes for cobas analyzers because corrosion on electrical contacts can disrupt liquid level detection, potentially causing sample carryover.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of medical harm (carryover) that is not excluded, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Corporation is recalling 3,946 sample probes used with the cobas 6000 Series System, cobas 8000 Modular Analyzer Series, and specific cobas c analyzers (c 311, c 501/502, c 701/702) and the cobas 8000 ISE. The recall is due to a design change implemented in 2015 that can cause corrosion on the sample probe electrical contacts. This corrosion may lead to a disturbance in the sample liquid level detection (LLD).
When the liquid level detection is disturbed, the affected sample probe may dip into the sample material deeper than intended. This excessive dipping may lead to carryover between samples. The source text states that a medical risk cannot be excluded as a result of this carryover.
The affected units were distributed nationwide in the United States. Specific lot numbers and catalog numbers are listed in the structured product information. Users of these devices should check their inventory against the provided lot numbers and contact Roche Diagnostics for instructions on how to proceed.
The recalled product
- Product
- Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immun
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 3,946
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)
- 0490233855
- 0490236427
- 0490238543
- 0490241937
- 0490248322
- 0490250880
- 0490235713
- 0490252029
- 0490256963 cobas c 501
- c 502 0490233762
- 0490233764
- 0490233766
- 0490233767
- 0490233777
- 0490235904
- 0490235905
- 0490235906
- 0490235907
- 0490235949
- 0490235950
Distribution
Distributed nationwide across the United States.
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