cobas b 221<6>Roche OMNI S6 system recallZ-1612-2018 · Roche Diagnostics Corporation · initiated Feb 22, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
FDA root cause category: Software design
What the company is doing
ROCHE sent an Urgent Medical Device Correction Letter dated February 22, 2018, via UPS to affected customers. Customers were instructed to complete the following: " 1) Use the Return to Setup and Exit buttons to ensure execution of scheduled AutoQC measurements as described in this Urgent Medical Device Correction (UMDC); 2) Check to see if the next scheduled AutoQC measurement is performed to ensure the AutoQC scheduler is working as expected; 3) If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site; 4) Complete the attached fax form (TP-00146) and fax it to 1-844-491-7776 or scan and email to [email protected]; 5) File this UMDC for future reference. Customers with questions should contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272.
Recall details
- Recall number
- Z-1612-2018
- Status
- Terminated
- Initiated by the company
- Feb 22, 2018
- Posted by the FDA
- May 3, 2018
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 1026 total products
- Product code
- CEM
- FDA submissions
- K032311
- Distribution
- USA ( nationwide)
Product description
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 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.
Code information (models, lots, serial numbers)
Catalog numbers: 3337154001 and 3337154692 UDI: 04015630018345
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- cobas b 221 <6> system 3337154001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, POTASSIUM1 recall43 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 79676).
- Z-1610-2018 · Terminatedcobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be use…
- Z-1611-2018 · TerminatedCobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be u…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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