Reported Nov 7, 2018 · Terminated
Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The…
Beckman Coulter Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
Software PackageSorting-Drive 4.2 User KitPart No. B73488
- Manufactured byBeckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. The system automates the process of sorting, decapping, and archiving samples. The Sorting-Drive 4.2. User Kit includes the Sorting-Drive Client software application that includes an option for manual printing of barcodes for sample tubes
- Lot codes and dates
- v4.2.1 (and 4.2, discontinued)
- Amount recalled
- 25
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
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. 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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