Roche cobas Liat Analyzer Recalled for Incorrect Default Settings
Roche Molecular Systems is recalling two cobas Liat Analyzers released with incorrect default settings that may produce erroneous results.
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 through erroneous medical results, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Roche Molecular Systems, Inc. is recalling two units of the cobas Liat Analyzer. The devices were distributed in North Carolina and Washington.
The recall was initiated because the devices were released with default pcal/gain settings for photometers instead of the required settings. These default settings can potentially lead to the generation of erroneous or invalid results.
The affected units are identified by US-IVD codes M1-E-00383 and M1-E-00434.
The recalled product
- Product
- cobas¿ Liat¿ Analyzer
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 2
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)
- US-IVD: M1-E-00383 & M1-E-00434
Distribution
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