Z-0358-2019Class III

Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman...

Name: Z-0358-2019 Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman...
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 Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes... 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 for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. Sorting Drive software version 4.2 was replaced...". 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-0358-2019
Classification: Class III
Status: Terminated
Initiated: 2018-05-24
Posted: 2018-10-31
Terminated: 2022-12-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which includes the Sorting-Drive 4.2.1 Software DVD. . The Sorting-Drive software facilitates the Laboratory Information System (LIS) connection to AutoMate 2500 Family systems. .
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 for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. Sorting Drive software version 4.2 was replaced by 4.2.1 (both versions 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 that 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: 495
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-0358-2019
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)