Software Package — Class III medical device recall Z-0357-2019
Terminated recall by Beckman Coulter Inc., reported 2018-11-07, distributed nationwide. Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting
| Recall number | Z-0357-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-05-24 |
| Classified | 2018-10-31 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2022-12-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, BR, CL, CN, CZ, DE, DK, DZ, ES, FR, GB, GR, HK, IE, IL, IN, IT, KR, LB, LT, MY, NL, PL, PT, QA, RO, SA, SE, TR, TW, ZA |
| Quantity | 29 |
| Reason classes | labeling, software |
| Model numbers | B95343 |
Product
Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0357-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.