RecallWatchUSA

Home / Recalls / Medical Devices

Beckman Coulter Inc. recalls Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The

Recalled November 7, 2018 · FDA recall Z-0353-2019 · Beckman Coulter

Hazard
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. · FDA Class III
Units
283
Sold at
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.

Description

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.

Product
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.
Manufacturer(s)
Beckman Coulter Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Beckman Coulter Inc. recalls Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The | RecallWatchUSA