Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 5, 2018
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample.
Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas system…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics, Inc. recalled RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 1032… - a moderate-severity action.
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 1032… was recalled by Siemens Healthcare Diagnostics, Inc. in September 5, 2018. Reason: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fract…. Check the official notice for the remedy. Verify recall #Z-2927-2018 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fract….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- September 5, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2927-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2927-2018) was formally reported on September 5, 2018, with the manufacturer initiating the action on July 16, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of Newark, DE. Federal records list the affected scope as 2248.
The documented reason for this recall is: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than e… Distribution data in the federal record shows the product reached: Nationwide distribution. Worldwide foreign distribution.. Distribution scope 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 - 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
2248
Related Recalls
6
0 from same agency
Product description
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample.
Reason for recall
Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2927-2018 |
| Date reported | September 5, 2018 |
| Date initiated | July 16, 2018 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Newark, DE |
| Affected scope | 2248 |
| Distribution | Nationwide distribution. Worldwide foreign distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2927-2018) 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? ▼
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 2248.
Why was this product recalled? ▼
Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2018. Severity: Moderate. Recall number: Z-2927-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution. Worldwide foreign distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2927-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 5, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.