Intelligent Peri-Analytical Workstation — Class III medical device recall Z-0353-2019
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-0353-2019 |
|---|---|
| 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 | 283 |
| Reason classes | labeling, software |
| Model numbers | A89492 |
Product
Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for specimen tracking and workload statistics or a physical workstation for manual sorting and label printing.
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. 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 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-0353-2019. 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.