Beckman Coulter Inc.: Medical Device Recall in 2018 - (Recall #: Z-0353-2019)

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:

Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for specimen tracking and workload statistics or a physical workstation for manual sorting and label printing.

Product Classification:

Class III

Date Initiated: May 24, 2018

Date Posted: November 7, 2018

Recall Number: Z-0353-2019

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 this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.

Status: Terminated

Product Quantity: 283

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