CLASS II Device recall · Reported 10 Feb 2016 · FDA Enforcement Report
Aqure System recalled by Radiometer America
Radiometer America is recalling Aqure System, distributed nationwide in the US. The recall was initiated on 29 Dec 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0748-2016
- FDA event ID
- 72959
- Recalling firm
- Radiometer America, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Dec 2015
- FDA classified
- 3 Feb 2016
- Reported
- 10 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 29 Dec 2015 | Recall initiated by company | |
| 3 Feb 2016 | Classified by FDA | +36 days |
| 10 Feb 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Where it was distributed
Worldwide Distribution-US (nationwide) including the states of PA, GA, MI, OH, VA, FL, AL, TX, OR, OK, TN, NY, and MA, and the countries of Austria, Czech Republic, Denmark, Estonia, United Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Finland, France, Germany, Hungry, Ireland, United Kingdom, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Russia, Singapore, South Africa, Republic of Korea, and Malaysia.
Nationwide AlabamaFloridaGeorgiaMassachusettsMichiganNew YorkOhioOklahomaOregonPennsylvaniaTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.
Which lots are affected?
Model Number: 933-599 Version 1.8.3
Where was it sold?
Worldwide Distribution-US (nationwide) including the states of PA, GA, MI, OH, VA, FL, AL, TX, OR, OK, TN, NY, and MA, and the countries of Austria, Czech Republic, Denmark, Estonia, United Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Finland, France, Germany, Hungry, Ireland, United Kingdom, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Russia, Singapore, South Africa, Republic of Korea, and Malaysia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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