Roche Recalls Five cobas p 612 Pre-analytical Systems in Texas and Washington
Roche Diagnostics is voluntarily recalling five cobas p 612 pre-analytical systems in Texas and Washington. The recall was initiated on December 27, 2016, and classified as Class II.
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, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source does not report specific injuries or illnesses, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Corporation is voluntarily recalling five units of the cobas p 612 pre-analytical system. These devices are used for pre-analytical sample handling, including de-capping, aliquotting, and sorting of samples for analysis. The recall was initiated on December 27, 2016, and is classified as Class II by the FDA.
The affected units were distributed in Texas and Washington. The specific serial numbers involved are 63004316, 63004416, 63004516, 63002816, and 63002916. The recall status is currently terminated, with a termination date of August 4, 2017.
The source text does not specify the exact reason for the recall or report any specific injuries or illnesses associated with these devices. Users of these systems should check their serial numbers against the list provided and contact Roche Diagnostics for further instructions.
The recalled product
- Product
- cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
- Manufacturer
- Roche Diagnostics Corporation
- Hazard
- Affected units
- 5
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)
- Serial Number 63004316 63004416 63004516 63002816 63002916
Distribution
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