Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 11, 2017
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Radiometer America Inc recalled AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers … - a moderate-severity action.
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers … was recalled by Radiometer America Inc in October 11, 2017. Reason: Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect res…. Check the official notice for the remedy. Verify recall #Z-3237-2017 with the FDA Devices before acting.
The recall
Radiometer America Inc issued this moderate-severity FDA Devices recall-Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect res….
- Moderate
- severity level
- Class II
- classification
- October 11, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3237-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3237-2017) was formally reported on October 11, 2017, with the manufacturer initiating the action on September 7, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Radiometer America Inc is listed as the recalling firm, operating out of Brea, CA. Federal records list the affected scope as 1669 Boxes.
The documented reason for this recall is: Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the… Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, So…. 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, 3 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 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
1669 Boxes
Related Recalls
6
3 from same agency
Product description
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
Reason for recall
Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92 5.85 kPa or 36.9 46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3237-2017 |
| Date reported | October 11, 2017 |
| Date initiated | September 7, 2017 |
| Recalling firm | Radiometer America Inc |
| Firm location | Brea, CA |
| Affected scope | 1669 Boxes |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapor… |
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-3237-2017) 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? ▼
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers. Recalled by Radiometer America Inc. Units affected: 1669 Boxes.
Why was this product recalled? ▼
Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92 5.85 kPa or 36.9 46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2017. Severity: Moderate. Recall number: Z-3237-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3237-2017) 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 October 11, 2017. 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.