Z-0355-2019Class III

Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured...

Name: Z-0355-2019 Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured...
Creator: Beckman Coulter Inc.
Published: 2018-05-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-05-24 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The... on 2018-05-24. FDA classified it as Class III and gives the reason as "Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes; version 4.2 was replaced by 4.2.1 (they both...". 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-0355-2019
Classification: Class III
Status: Terminated
Initiated: 2018-05-24
Posted: 2018-10-31
Terminated: 2022-12-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. . The Sorting-Drive 4.2.1 User Kit includes the Sorting-Drive Client software application that includes an option for manual printing of barcodes for sample tubes; version 4.2 was replaced by version 4.2.1 (they both contain the same option for manual barcode printing). This function is primarily used to copy an existing barcode ID to replace the label of an individual sample tube because the original label is deteriorated.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes; version 4.2 was replaced by 4.2.1 (they both contain the same option for manual barcode printing). When printing consecutively numbered tube labels using this optional Barcode Counter function, the system incorrectly converts numbers with consecutive multiple zeroes in the middle, potentially leading to wrong barcode IDs.The firm reports this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.
Root cause tag: software
FDA root cause: Software change control
Action: On 6/4/2018 Beckman Coulter (BEC) reported that the issue will be corrected via a field modification performed by Field Service. BEC reported that they do not intend to send a customer letter for this issue.US customers can contact the Technical Support Troubleshooting Hotline at (800) 854-3633.
Quantity in commerce: 54
Distribution: Worldwide Distribution: US (nationwide) and countries of: Algeria, Argentina, Austria, Belgium, Brazil, Chile, China, Czech Republic, Denmark ,France, Germany, Greece ,Hong Kong, India, Ireland, Israel, Italy ,Republic of Korea, Lebanon, Lithuania ,Malaysia, Netherlands, Poland, Portugal , Qatar, Romania, Russian Federation, Saudi Arabia ,South Africa , Spain, Sweden, Taiwan, Turkey , and United Kingdom.
Product codes and lots: v4.2.1 (and 4.2, discontinued)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0355-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0353-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0354-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0355-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0356-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0357-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0358-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0359-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)