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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog numbers: 3337154001 and 3337154692 UDI: 04015630018345
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Roche Diagnostics Corporation
- Reason for Recall:
- The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Catalog numbers: 3337154001 and 3337154692 UDI: 04015630018345
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1612-2018
Related Recalls
Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Roche Diagnostics
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Roche Diagnostics
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.