iChem VELOCITY Urine Chemistry Analyzer — Class II medical device recall Z-0843-2020
Terminated recall by Beckman Coulter Inc., reported 2020-01-29, distributed nationwide. Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCI
| Recall number | Z-0843-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2019-11-07 |
| Classified | 2020-01-23 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2023-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, ES, FR, GB, GH, GR, GT, HK, HR, HU, ID, IL, IN, IT, JO, JP, KR, KW, LB, MA, MX, MY, NG, NL, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SG, SK, TH, TR, TW, UA, VE, VN, ZA |
| Quantity | 4,314 units |
Product
iChem VELOCITY Urine Chemistry Analyzer
Reason for recall
Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.
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-0843-2020. 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.