The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2446-2015·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 is classified as FDA Class II. The hazard involves a risk of harm (erroneously low PO2 results) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 82 units of the cobas b 123 Fluid Pack COOX (Catalog 05169992001). The affected lots are 21446113, 21446123, 21446153, 21446183, and 21446203, with expiration dates ranging from August 8, 2015, to October 1, 2015.

The recall was initiated because of a calibration issue with the PO2 parameter that causes quality control failures. This issue may not be detected because QC results can fall below mean values while still remaining within 2 standard deviation limits. The defect creates a potential for erroneously low PO2 results in patient samples, particularly in blood samples with PO2 values below 50 mmHg.

The product was distributed nationwide in the states of Louisiana, South Carolina, California, Texas, Nebraska, Virginia, and West Virginia, as well as in Puerto Rico. Healthcare facilities should stop using the affected fluid packs and contact Roche Diagnostics for further instructions.

The recalled product

Product
cobas b 123 Fluid Pack COOX REF 05169992001 200 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 (6)

  • cobas b 123 Fluid Pack COOx Catalog 05169992001
  • lot numbers 21446113 (exp 8/8/2015)
  • 21446123 (exp 8/18/2015)
  • 21446153 ( exp 9/18/2015)
  • 21446183 (exp 9/19/2015)
  • and 21446203 (exp 10/01/2015)

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 →

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