Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0356-2019 — 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 s

U.S. FDA — Device Enforcement · United States · 2018-05-24 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0356-2019
Date of alert: 2018-05-24
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Beckman Coulter Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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