Recall Z-0359-2019— Beckman Coulter Inc.

Class III FDA medical device recall by Beckman Coulter Inc., initiated 2018-05-24, terminated 2022-12-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the Sorting-Drive 4.2.1 User Kit (PN B95347) which includes the Sorting-Drive 4.2.1 Software DVD (PN B95346). This software version includes an option for manual barcode printing for sample tubes. Sorting-Drive software facilitates the Laboratory Information System (LIS) connection to AutoMate 2500 Family systems.. 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.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 that this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected..

Recalling firm

Beckman Coulter Inc.

Classification

Class III

Status

Terminated

Initiated

2018-05-24

Terminated

2022-12-08

Firm location

Brea, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.