Z-0355-2019 Class III Terminated
Recalled by Beckman Coulter Inc.
— Brea, CA
FDA device recall Z-0355-2019 was initiated by Beckman Coulter Inc. on May 24, 2018 and is designated Class III. 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… The recall status is terminated (terminated Dec 8, 2022). Affected quantity: 54.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 7, 2018
- Initiation Date
- May 24, 2018
- Termination Date
- Dec 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54
Product Description
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.
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.
Distribution Pattern
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.
Code Information
v4.2.1 (and 4.2, discontinued)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0355-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.