CLASS II Device recall · Reported 22 Mar 2017 · FDA Enforcement Report
The ABL800 recalled by Radiometer America
Radiometer America is recalling The ABL800, distributed nationwide in the US. The recall was initiated on 26 Jan 2017 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-1463-2017
- FDA event ID
- 76339
- Recalling firm
- Radiometer America, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jan 2017
- FDA classified
- 14 Mar 2017
- Reported
- 22 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 26 Jan 2017 | Recall initiated by company | |
| 14 Mar 2017 | Classified by FDA | +47 days |
| 22 Mar 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
Product as listed by the FDA
The ABL800 Model#:All
Where it was distributed
U.S. distribution to the following; nationwide. Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.
Questions about this recall
Why was it recalled?
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
Which lots are affected?
The affected analyzers are serial numbers 393-090R0027N001 to present.
Where was it sold?
U.S. distribution to the following; nationwide. Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.
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.
Other products in this recall event
1 other product · FDA event 76339This product is part of a recall event; the main page for the event is ABL90 Flex recalled by Radiometer America.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ABL90 Flex recalled by Radiometer America | Radiometer America | Other | Nationwide |
More recalls from Radiometer America
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ABL90 FLEX Analyzer recalled by Radiometer America | Radiometer America | Device Malfunction | 36 states |
| Device | CLASS II | ABL800 FLEX with Crea recalled by Radiometer America | Radiometer America | Other | 31 states |
| Device | CLASS II | ABL800 analyzer recalled by Radiometer America | Radiometer America | Device Malfunction | Nationwide |
| Device | CLASS II | ABL90 FLEX analyzers recalled by Radiometer America | Radiometer America | Device Malfunction | CA |
| Device | CLASS II | ABL800 analyzer with Flexq module recalled by Radiometer America | Radiometer America | Other | Nationwide |
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| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |