Roche OMNI S Cassette Recall for Incorrect Urea Measurement Results
Roche is recalling 97 MSS Cassette units for the OMNI S Analyzer due to a software error that may cause incorrect urea results, potentially delaying diagnosis of inborn disorders in children.
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-harm product (medical device) where injury has not yet been reported, but the potential for delayed diagnosis of serious conditions in children meets the criteria for a High severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 97 units of the MSS CASSETTE GLU/LAC/UREA (BUN) used with the Roche OMNI S Analyzer (cobas b 221<6>Roche OMNI S6 system). The recall is due to a software error in the measurement procedure that may sporadically generate incorrect urea results. These errors cannot be detected by standard quality control (QC) and may only be identified if a comparison result from a second measurement is available.
The primary risk involves children, where decreased urea results can indicate inborn disorders or urea cycle issues. False normal urea values could lead to a delayed or incorrect diagnosis of such conditions. While the risk for the overall patient population is considered remote, falsely normal results may result in necessary examinations not being carried out, potentially delaying diagnosis and treatment. The source notes that a medical risk cannot be entirely excluded, though no severe adverse health effects are expected.
The affected units were distributed nationwide, including in AL, CA, CO, CT, FL, IL, IN, KS, MD, MI, MO, NC, NE, NJ, NM, NY, OH, OK, PA, PR, SC, TX, VA, and WI. All lots within shelf life are affected. Healthcare facilities should contact Roche Diagnostics Operations, Inc. for instructions on how to return the affected cassettes.
The recalled product
- Product
- MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calc
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 97
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)
- Lot Number(s): All lots within shelf life. Expiration Date(s): All
Distribution
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