CLASS II Device recall · Reported 3 Jun 2020 · FDA Enforcement Report
Abl90 Flex Plus recalled by Radiometer Medical ApS
Radiometer Medical ApS is recalling Abl90 Flex Plus, distributed nationwide in the US. The recall was initiated on 21 Nov 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-2138-2020
- FDA event ID
- 85390
- Recalling firm
- Radiometer Medical ApS, Bronshoj, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Nov 2019
- FDA classified
- 28 May 2020
- Reported
- 3 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Nov 2019 | Recall initiated by company | |
| 28 May 2020 | Classified by FDA | +189 days |
| 3 Jun 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.
Product as listed by the FDA
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Where it was distributed
Worldwide distribution - US Nationwide. Also distributed OUS.
Questions about this recall
Why was it recalled?
The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.
Which lots are affected?
ABL90 FLEX PLUS Model no. 393-092: R0014 - R0195; and Spare Part Hemolyzer Units (902-980): R0526 - R0941; Model Number 393-092.
Where was it sold?
Worldwide distribution - US Nationwide. Also distributed OUS.
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 85390This product is part of a recall event; the main page for the event is ABL90 FLEX recalled by Radiometer Medical ApS.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ABL90 FLEX recalled by Radiometer Medical ApS | Radiometer Medical ApS | Other | Nationwide |
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