Z-2098-2021Class II

SoftCytogenetics

Name: Z-2098-2021 SoftCytogenetics
Creator: Soft Computer Consultants, Inc.
Published: 2021-03-31
License: https://open.fda.gov/license/

SCC Soft Computer / initiated 2021-03-31 / Terminated / root cause: software

FDA source

Soft Computer Consultants, Inc. began a recall of SoftCytogenetics on 2021-03-31. FDA classified it as Class II and gives the reason as "Software is given wrong results going out to HIS on test that had reruns". 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-2098-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-31
Posted: 2021-07-20
Terminated: 2023-02-14
Recalling firm: SCC Soft Computer
Product: SoftCytogenetics
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Software is given wrong results going out to HIS on test that had reruns.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Dear SoftCytogentics Customer, The purpose of this letter is to advise you that SCC is voluntarily recalling SoftCytogenetics 4.1.11.20 and 4.1.12.11. There are software errors in these versions which SCC has designated to pose a potential risk-to-health issue. Reason for the Voluntary Recall: This task is to inform you of functionality in SoftCytogentics which SCC has designated to be a potential patient Risk-to-Health issue. For clients using Outbound Result Reporting with Resulting Profiles including Test Chapter macros, for cases that had multiple runs for reportable fields included to the Test Chapter macro, results from incorrect run may be sent outbound in HL7 message. Risk to Patient Care: When the results for test are processed with more than one run, and test uses the outbound reporting configuration of Resulting Profile* with Test Result macro added within, then some of results related to last reportable run can be sent outbound with values coming from any of the previous runs. These values are picked randomly from the previous runs. YOUR FACILITY DOES NOT CURRENTLY USE THIS CONFIGURATION. A hot fix would be required if you decide to implement this result reporting configuration prior to the next patch. Corrective Action: This issue will be corrected in the next software patch. Actions to be taken by the Customer/User: Please acknowledge receipt of this task and choose one of the following options: Workflow or functionality not used Agree to use alternative working solution Request hot fix if you decide to implement this result reporting configuration prior to the next patch.
Quantity in commerce: 5
Distribution: US Nationwide Distribution in the states of CA, FL, MN and NJ.
Product codes and lots: Versions: 4.1.11.20, 4.1.12.11 and 4.1.15.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2098-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2098-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-19

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)