Home / Recalls / Beckman Coulter Inc. / Z-0358-2019

Z-0358-2019 Class III Terminated

Recalled by Beckman Coulter Inc. — Brea, CA

FDA device recall Z-0358-2019 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 for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. Sorting Drive software version… The recall status is terminated (terminated Dec 8, 2022). Affected quantity: 495.

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: 495

Product Description

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 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.

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-0358-2019
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.

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