Recall Z-0355-2019
Beckman Coulter Inc. · initiated May 24, 2018
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, 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 Sorting-Drive 4.2.1 User Kit includes the Sorting-Drive Client software application that includes an option for manual printing of barcodes for sample tubes; version 4.2 was replaced by version 4.2.1 (they both contain the same option for manual barcode printing). This function is primarily used to copy an existing barcode ID to replace the label of an individual sample tube because the original label is deteriorated.
Codes / lots: v4.2.1 (and 4.2, discontinued)
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; version 4.2 was replaced by 4.2.1 (they both 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-determined cause: Software change control
Action taken
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.
Details
- Recall number
- Z-0355-2019
- Initiated
- May 24, 2018
- Terminated
- December 8, 2022
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 54
- Distribution
- 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…
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0353-2019 Class III | Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the… | 05/24/2018Terminated |
| Z-0354-2019 Class III | Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the… | 05/24/2018Terminated |
| Z-0356-2019 Class III | Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the… | 05/24/2018Terminated |
| Z-0357-2019 Class III | Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the… | 05/24/2018Terminated |
| Z-0358-2019 Class III | Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the… | 05/24/2018Terminated |
| Z-0359-2019 Class III | Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the… | 05/24/2018Terminated |