Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH 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.
FDA Recall Z-0357-2019 · Posted None
Advertisement
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2018-05-24
Date Terminated2022-12-08
Product Quantity29
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.
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.
Firm Action
On 6/4/2018 Beckman Coulter (BEC) reported that the issue will be corrected via a field modification performed by Field Service. BEC reported that they do not intend to send a customer letter for this issue.US customers can contact the Technical Support Troubleshooting Hotline at (800) 854-3633.
Root Cause
Software change control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement