Roche Bulk Loader Module Recalled for Sample Contamination Risk
Roche Diagnostics is recalling Bulk Loader Modules for cobas p 512/612 instruments because sample tubes may open during transport, causing system and sample contamination.
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 3/5 (High).
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 harm (sample and system contamination) where specific injury or illness reports are not stated in the source text, fitting the criteria for a High severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the Bulk Loader Module for cobas p 512/612 pre-analytical instruments. This in vitro diagnostic machine component is used for pre-analytical sample handling, including de-capping, aliquoting, and sorting of samples for analysis.
The recall was initiated because sample tubes may inadvertently open and spill during transport from the Bulk Loader Module to the cobas p 512/p 612 pre-analytical instruments. This failure can cause contamination of the system as well as adjacent samples during processing.
The affected product was distributed to Texas only. Users of these instruments should stop using the Bulk Loader Module and contact Roche Diagnostics for further instructions.
The recalled product
- Product
- Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 1
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 (5)
- During transport from the Bulk Loader Module (BLM)
- catalog number 07135645001
- to the cobas p 512/p 612 pre-analytical instruments
- sample tubes may inadvertently open and spill
- causing contamination of the system.
Distribution
Distributed in 1 state:
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