Roche Diagnostics Operations, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0522-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, 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.

Product Classification:

Class II

Date Initiated: November 14, 2012

Date Posted: December 19, 2012

Recall Number: Z-0522-2013

Event ID: 63680

Reason for Recall:

It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications, but within the upper

Status: Terminated

Product Quantity: 23 units of Fluid Pack COOX, 200 were distributed

Code Information:

Part number: 05169992001 cobas b 123 Fluid Pack COOX, 200 with Lot# 21426121 and Lot# 21426171.

Distribution Pattern:

Nationwide Distribution including NE and AZ.

Voluntary or Mandated:

Voluntary: Firm initiated