CLASS II Device recall · Reported 5 Feb 2020 · FDA Enforcement Report
Aqure basic sytem, Flexlink recalled by Radiometer Medical ApS
Radiometer Medical ApS is recalling Aqure basic sytem, Flexlink, distributed nationwide in the US. The recall was initiated on 8 Aug 2019 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-0864-2020
- FDA event ID
- 84496
- Recalling firm
- Radiometer Medical ApS, Bronshoj, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2019
- FDA classified
- 24 Jan 2020
- Reported
- 5 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 8 Aug 2019 | Recall initiated by company | |
| 24 Jan 2020 | Classified by FDA | +169 days |
| 5 Feb 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
Where it was distributed
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV; and countries of: Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Italy, Japan (Tokyo-not a country but it was listed), Netherlands, Norway, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Nationwide AlabamaArkansasArizonaCaliforniaFloridaGeorgiaIowaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriMississippiMontanaNorth Carolina
Questions about this recall
Is Aqure basic sytem, Flexlink recalled?
Yes. Radiometer Medical ApS recalled Aqure basic sytem, Flexlink on 8 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0864-2020.
Why was it recalled?
The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.
Which lots are affected?
Software version 2.3.5 and below
Where was it sold?
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV; and countries of: Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Italy, Japan (Tokyo-not a country but it was listed), Netherlands, Norway, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Radiometer Medical ApS
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Radiometer ABL90 Series - Radiometer ABL90 FLEX recalled | Radiometer Medical ApS | Lead & Heavy Metals | 49 states |
| Device | CLASS II | Aqure REF 933-599 Software Versions 2.5.2 recalled | Radiometer Medical ApS | Packaging Defects | Nationwide |
| Device | CLASS II | ABL800 Flex Analyzer recalled by Radiometer Medical ApS | Radiometer Medical ApS | Other | Nationwide |
| Device | CLASS II | Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL recalled | Radiometer Medical ApS | Sterility | Nationwide |
| Device | CLASS II | Radiometer ABL90 Flex Plus Analyzer with E3800 PC units recalled | Radiometer Medical ApS | Other | Nationwide |
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