Z-0864-2020Class II

AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999

Name: Z-0864-2020 AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999
Creator: Radiometer Medical ApS
Published: 2019-08-08
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2019-08-08 / Terminated / root cause: software

FDA source

Radiometer Medical ApS began a recall of 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... on 2019-08-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0864-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-08
Posted: 2020-01-24
Terminated: 2022-06-06
Recalling firm: Radiometer Medical ApS
Product: 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.
Product code: OUG Medical Device Data System
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.
Root cause tag: software
FDA root cause: Software design
Action: On 07/15/2019, the firm, Radiometer America, Inc., sent an "Urgent: Medical Device Correction" to customers via FedEx with tracking and email to inform them that the firm has become aware that there is a potential problem related to its system that may result in patient mix-up when connected to some third-party devices. This recall affects all system below version 2.3.5. On September 24th, the firm sent a updated letter via email which updated that only 7 third party devices could be potentially affected (Originally 10 third party devices). The firm is instructing customers to: If the customer's affected system is connected to a third-party device, the Recalling Firm is requesting the customer to inform operators to cease performing queries as described in the scenario above until the affected system has been corrected by the Recalling Firm's representative. Additionally, the firm is asking that the customer please complete the Recall Response Form (last page) and return it to the fax number (714-582-0806) or email address provided ([email protected]). For any additional questions, customers are instructed to contact their Recalling Firms representative; or 440-925-34875 or email: [email protected].
Quantity in commerce: 947
Distribution: 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.
Product codes and lots: Software version 2.3.5 and below

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0864-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0864-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)