Roche Diagnostics Operations, Inc.: Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be u

Is my product affected?

Omni Micro-electrode/reference electrode for cobas b221 analyzer. 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 he

• UPC 03337103001
• UPC 03337111001
• UPC 03337154001
• UPC 03337138001
• UPC 03337120001
• UPC 03337146001
• UPC 03337111692
• UPC 03337138692
• UPC 03337154692

Check against the official notice below — it lists the full affected range.

What happened

Roche Diagnostics Operations, Inc. recalled 492 Omni micro-electrode/reference electrode devices for cobas b221 analyzers distributed nationwide, including Puerto Rico, Guam, and all U.S. states. The recall was issued because the default normal value references in the cobas b221 analyzer are inconsistent with those in other blood gas instruments and do not match the reference ranges listed in the device's Instructions for Use or in reference literature sources.

The affected devices have part numbers 03337103001, 03337111001, 03337154001, 03337138001, 03337120001, 03337146001, 03337111692, 03337138692, or 03337154692. The source document does not specify a remedy or what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.

Details from the source

Reason for recall: The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source. Distribution: Nationwide Distribution including Puerto Rico and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI. Quantity: 492 devicees Lot/code info: Model/Catalog/Part Number: 1. 03337103001 2. 03337111001 3. 03337154001 4. 03337138001 5. 03337120001 6. 03337146001 7. 03337111692 8. 03337138692 9. 03337154692

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.2014-09-17
• Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.2014-09-04
• The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System i2014-09-02
• The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System i2014-09-02
• The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System i2014-09-02

All FDA (Device enforcement) recalls