Beckman Coulter Inc.: Medical Device Recall in 2018 - (Recall #: Z-0359-2019)

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:

Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the Sorting-Drive 4.2.1 User Kit (PN B95347) which includes the Sorting-Drive 4.2.1 Software DVD (PN B95346). This software version includes an option for manual barcode printing for sample tubes. Sorting-Drive software facilitates the Laboratory Information System (LIS) connection to AutoMate 2500 Family systems.

Product Classification:

Class III

Date Initiated: May 24, 2018

Date Posted: November 7, 2018

Recall Number: Z-0359-2019

Event ID: 80434

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.

Status: Terminated

Product Quantity: 58

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