🔍 RecallPedia

Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option

Class I - Dangerous
🏥 Medical Devices Recalled: September 3, 2015 Roche Diagnostics Operations Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Models: cobas b 123 <2> POC system: 05122252001 cobas b 123 < 4 > POC system: 05122287001 Serial numbers: 11074 2274 2550 2302 2304 2309 1253 2420 2337 2147 2389 2418 2425 1749 2462 2338 2339 1850 2328 2500 1374 2301 1349 2400 2344 2350 1860 1941 2006 2128
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 Operations, Inc.
Reason for Recall:
under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b 123 <4> POC system. The issue occurs when the software function [AutoQC as follow-up] is configured to run all three levels of AutoQC only after a Fluid Pack change, but not after a Sensor Cartridge change. When both are changed simultaneously, starting with the Sensor Cartridge and followed by the Fluid Pack, the analyzer carries out only the follow-up actions associated with the Sensor Cartridge change after completing the change workflow. As a result, no follow-up AutoQC is performed and the three expected AutoQC measurements for the Fluid Pack change are not carried out. Without running quality control, there is a remote possibility that system issues would not be detected and wrong results would not be excluded on all parameters: pH, PO2, PCO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, SO2, O2Hb, COHb, MetHb, HHb, and Bili.
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 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option

Product Codes/Lot Numbers:

Models: cobas b 123 <2> POC system: 05122252001 cobas b 123 < 4 > POC system: 05122287001 Serial numbers: 11074 2274 2550 2302 2304 2309 1253 2420 2337 2147 2389 2418 2425 1749 2462 2338 2339 1850 2328 2500 1374 2301 1349 2400 2344 2350 1860 1941 2006 2128

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1077-2017

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