Z-1430-2020Class II

Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008...

Name: Z-1430-2020 Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008...
Creator: Normand-Info S.A.S.U.
Published: 2019-08-15
License: https://open.fda.gov/license/

Normand-Info S.A.S.U. / initiated 2019-08-15 / Terminated

FDA source

Normand-Info S.A.S.U. began a recall of Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems on 2019-08-15. FDA classified it as Class II and gives the reason as "A patch was released for a critical remote code execution vulnerability in remote desktop services. This vulnerability can be exploited remotely without authentication on certain operating systems. An attacker who...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1430-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-15
Posted: 2020-03-03
Terminated: 2021-06-03
Recalling firm: Normand-Info S.A.S.U.
Product: Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: A patch was released for a critical remote code execution vulnerability in remote desktop services. This vulnerability can be exploited remotely without authentication on certain operating systems. An attacker who successfully exploited this vulnerability could execute arbitrary code on the target system; then install programs; view, change, or delete data; or create new accounts with full user rights. If the vulnerability could be exploited locally, it would lock down the computer.
FDA root cause: Other
Action: On 08/15/19, Urgent Medical Device Recall notices, dated 08/09/19, were mailed to customers informing them to follow the instructions in the notice to download the patch for their system(s). In addition, customers were asked to share this information with laboratory staff, to retain the notification as part of their laboratory Quality System documentation, and to complete and return the response form. If you are a centralized license holder, please provide the other affected laboratories of your organization or association with a copy of this letter. The latest information on cybersecurity can be found on the following website: https://www.beckmancoulter.com/en/about-beckman-coulter/product-security/product-security-updates. Customers with additional questions were encouraged to contact the firm via email at website: http://www.beckmancoulter.com. The following number was also provided: (800) 526-3821
Quantity in commerce: 6479
Distribution: U.S.: NY, AZ, FL, NJ, MA, OH, CA, IL, NC, OK, IN, KY, OR, MI, WI, PA, UT, GA, VA, TX, NE, SD, IA, MN, MD, DE, SC, MT, WV, LA, MO, TN, NM, NV, HI, WA, WY, AL, AR, MS, RI, ID, ME, DC, ND, AK, CO, CT, KS, NH, VT
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1430-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1430-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-03

Product code JQP

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)