ModerateClass IITerminated

FDA Devices recall · Reported February 1, 2017

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 an

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-1077-2017.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution including CA, LA, NE, PR, SC, TX, VA, and WV.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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…

Recall #: Z-1077-2017
Affected scope: 30
Initiated: September 3, 2015

Compiled from official public sources by the publisher. · Updated September 2026

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Roche Diagnostics Operations, Inc. recalled Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for wh… - a moderate-severity action.

Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for wh… was recalled by Roche Diagnostics Operations, Inc. in February 1, 2017. Reason: under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the…. Check the official notice for the remedy. Verify recall #Z-1077-2017 with the FDA Devices before acting.

The recall

Roche Diagnostics Operations, Inc. issued this moderate-severity FDA Devices recall-under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the….

Moderate
severity level: 30 units
affected scope: Class II
classification: February 1, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1077-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product 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

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1077-2017
Date reported	February 1, 2017
Date initiated	September 3, 2015
Recalling firm	Roche Diagnostics Operations, Inc.
Firm location	Indianapolis, IN
Affected scope	30
Distribution	Nationwide Distribution including CA, LA, NE, PR, SC, TX, VA, and WV

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

30 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1077-2017) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-1077-2017.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution including CA, LA, NE, PR, SC, TX, VA, and WV.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported February 1, 2017. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026