ModerateClass IITerminated

FDA Devices recall · Reported December 7, 2016

MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solut

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on December 7, 2016. Severity: Moderate. Recall number: Z-0673-2017.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution including ALCA CO CT FL IL IN KS MD MI MO NC NE NJ NM NY OH OK PA PR SC TX VA and WI.

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.

Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue…

Recall #: Z-0673-2017
Affected scope: 97
Initiated: October 31, 2016

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

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Roche Diagnostics Operations, Inc. recalled MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Ro… - a moderate-severity action.

MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Ro… was recalled by Roche Diagnostics Operations, Inc. in December 7, 2016. Reason: Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be dete…. Check the official notice for the remedy. Verify recall #Z-0673-2017 with the FDA Devices before acting.

The recall

Roche Diagnostics Operations, Inc. issued this moderate-severity FDA Devices recall-Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be dete….

Moderate
severity level: 97 units
affected scope: Class II
classification: December 7, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0673-2017 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

MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate

Reason for recall

Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable if comparison result of a second measurement is available. The cause for this issue is an error in the software measurement procedure. In children, decreased urea results can point at inborn disorders or urea cycle. Therefore, false normal urea values could lead to delayed/incorrect diagnosis of such a disorder. Besides the patients most at risk, the risk for the overall patient population with falsely low or high values is considered remote. No severe adverse health effects are expected; but, unnecessary diagnostic measures may be initiated. Falsely normal results may result in further necessary examination not being carried out, with the possibility of a delay in the diagnosis and treatment. A medical risk cannot entirely be excluded.

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-0673-2017
Date reported	December 7, 2016
Date initiated	October 31, 2016
Recalling firm	Roche Diagnostics Operations, Inc.
Firm location	Indianapolis, IN
Affected scope	97
Distribution	Nationwide Distribution including ALCA CO CT FL IL IN KS MD MI MO NC NE NJ NM NY OH OK PA PR SC TX VA and WI

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

Scale of Impact

97 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-0673-2017) 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 December 7, 2016. Severity: Moderate. Recall number: Z-0673-2017.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution including ALCA CO CT FL IL IN KS MD MI MO NC NE NJ NM NY OH OK PA PR SC TX VA and WI.

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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This recall: FDA Devices, reported December 7, 2016. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026