Roche Diagnostics Operations, Inc.: 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 calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate

Recall number

Z-0673-2017

Recalling firm

Roche Diagnostics Operations, Inc.

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 calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate

Status

Terminated

Initiated

2016-10-31

Posted

not on file

Terminated

2017-09-18

Reason

Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable if comparison result of a second measurement is available. The cause for this issue is an error in the software measurement procedure. In children, decreased urea results can point at inborn disorders or urea cycle. Therefore, false normal urea values could lead to delayed/incorrect diagnosis of such a disorder. Besides the patients most at risk, the risk for the overall patient population with falsely low or high values is considered remote. No severe adverse health effects are expected; but, unnecessary diagnostic measures may be initiated. Falsely normal results may result in further necessary examination not being carried out, with the possibility of a delay in the diagnosis and treatment. A medical risk cannot entirely be excluded.

Root cause

Software design

Action

Roche sent an Urgent Medical Correction letter dated October 31, 2016, to all affected customers. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Actions Required " Use the workaround outlined in this Urgent Medical Device Correction (UMDC) for Urea measurement until the updated software version is available. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " Complete the attached fax form and fax it to 1-877-766-7471. " File this UMDC for future reference. Questions Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272 if you have questions about the information contained in this UMDC.

Quantity

97

Distribution

Nationwide Distribution including ALCA CO CT FL IL IN KS MD MI MO NC NE NJ NM NY OH OK PA PR SC TX VA and WI

Lot, serial or model codes

Lot Number(s): All lots within shelf life. Expiration Date(s): All

510(k) numbers

["K032311"]

PMA numbers

not on file

Product code

CDS

Firm FEI

1823260

Firm city

Indianapolis

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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