The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2447-2015·Announced 2015-09-02

Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential diagnostic errors without confirmed adverse events.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 82 units of the cobas b 123 Fluid Pack COOX (Catalog 05170036001). The affected units are from lot numbers 21446113 (expiration 9/5/2015) and 21446153 (expiration 9/24/2015). These products were distributed nationwide in the states of Louisiana, South Carolina, California, Texas, Nebraska, Virginia, and West Virginia, as well as Puerto Rico.

The recall is due to a calibration issue with the PO2 parameter that may cause quality control failures and erroneously low PO2 results in patient samples. This issue is particularly relevant for blood samples with PO2 values below 50 mmHg. The problem may not be detected because QC results can fall below mean values while still remaining within 2 standard deviation limits.

Healthcare facilities and users of the cobas b 123 POC system should stop using the affected Fluid Packs and contact Roche Diagnostics for instructions on return or replacement.

The recalled product

Product
cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: 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…
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
82

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • cobas b 123 Fluid Pack COOx Catalog 05170036001
  • lot numbers 21446113 (exp 9/5/2015)
  • and 21446153( exp 9/24/2015)

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Roche Diagnostics Operations, Inc.

See all →

Same hazard · diagnostic error

See all →

Similar recalls