CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report
ABL90 Flex Plus Analyzer recalled by Radiometer Medical ApS
Radiometer Medical ApS is recalling ABL90 Flex Plus Analyzer, distributed nationwide in the US. The recall was initiated on 3 Feb 2020 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-1761-2020
- FDA event ID
- 85326
- Recalling firm
- Radiometer Medical ApS, Bronshoj, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Feb 2020
- FDA classified
- 22 Apr 2020
- Reported
- 29 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Feb 2020 | Recall initiated by company | |
| 22 Apr 2020 | Classified by FDA | +79 days |
| 29 Apr 2020 | 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 firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Where it was distributed
Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada, Netherlands, China, Croatia, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, South Korea, United Kingdom, Poland, Australia, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.
Which lots are affected?
All software versions below 3.4 MR2
Where was it sold?
Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada, Netherlands, China, Croatia, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, South Korea, United Kingdom, Poland, Australia, 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 85326| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ABL90 FLEX Analyzer recalled by Radiometer Medical ApS | Radiometer Medical ApS | Packaging Defects | Nationwide |
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 | Device Malfunction | 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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