Recall Z-0356-2019 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter Inc.
Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes the iPAW software application CD (version 4.2). 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.
| Date | May 24, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software change control |
| 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. |
| Quantity | 14 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.