CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report
ABL90 FLEX Analyzer recalled by Radiometer America
Radiometer America is recalling ABL90 FLEX Analyzer, distributed in 36 states. The recall was initiated on 10 Jul 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-2320-2019
- FDA event ID
- 83312
- Recalling firm
- Radiometer America, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jul 2019
- FDA classified
- 22 Aug 2019
- Reported
- 28 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Jul 2019 | Recall initiated by company | |
| 22 Aug 2019 | Classified by FDA | +43 days |
| 28 Aug 2019 | 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
Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Where it was distributed
US: AB, AL, AR, BC, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV OUS: Canada, Netherland, China, Czech Republic, Denmark, Germany, Spain, France, Hugary, , indiat Japan, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Brazil, and Mexico
AlabamaArkansasCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriMississippi
Questions about this recall
Why was it recalled?
Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
Which lots are affected?
All lots with the operating system versions - RXPE -UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX
Where was it sold?
US: AB, AL, AR, BC, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV OUS: Canada, Netherland, China, Czech Republic, Denmark, Germany, Spain, France, Hugary, , indiat Japan, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Brazil, and Mexico
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.
More recalls from Radiometer America
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | AutoCheck5+, Level 2, specifically designed recalled | Radiometer America | Device Malfunction | Nationwide |
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