iChemVELOCITY Strips — Class II medical device recall Z-1535-2020
Terminated recall by Beckman Coulter, Inc., reported 2020-04-01, distributed in PR. The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY S
| Recall number | Z-1535-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Miami, FL, United States |
| Recall initiated | 2020-02-17 |
| Classified | 2020-03-20 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2021-05-13 |
| Distributed | PR |
| Countries outside the US | CA, TW |
| Quantity | 10,822 vials |
| UPC / GTIN / UDI-DI | 10837461002628 |
| Lot numbers | 7212269M |
| Model numbers | 800-7212 |
Product
iChemVELOCITY Strips, Catalog 800-7212
Reason for recall
The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
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-1535-2020. 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.