Beckman Coulter Inc.: Medical Device Recall in 2018 - (Recall #: Z-0354-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, 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 system automates the process of sorting, decapping, and archiving samples. The Sorting-Drive 4.2. User Kit includes the Sorting-Drive Client software application that includes an option for manual printing of barcodes for sample tubes.

Product Classification:

Class III

Date Initiated: May 24, 2018

Date Posted: November 7, 2018

Recall Number: Z-0354-2019

Event ID: 80434

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. 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.

Status: Terminated

Product Quantity: 25

Code Information:

v4.2.1 (and 4.2, discontinued)

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.

Voluntary or Mandated:

Voluntary: Firm initiated