FDA Device recall Z-0358-2019
Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc
- FDA Device
- Class III
- terminated
- Published 2018-11-07
On 2018-11-07 the FDA classified a Class III recall of Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc by Beckman Coulter, citing 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 D….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0358-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-05-24 |
| Published | 2018-11-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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. .
Reason
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.
Identifiers
| code_info | v4.2.1 (and 4.2, discontinued) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0358-2019%22
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