medical Class III Updated 2018-11-07

Beckman Coulter Inc. recalls Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufa

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: v4.2.1 (and 4.2, discontinued)
View official government recall

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