iChem VELOCITY Urine Chemistry Strips — Class II medical device recall Z-1937-2019
Terminated recall by Beckman Coulter Inc., reported 2019-07-10, distributed nationwide. Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the ur
| Recall number | Z-1937-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-10-18 |
| Classified | 2019-07-03 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2020-11-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CL, CO, MX, PE, PH, SG, TW |
| Lot numbers | 7212143 |
| Model numbers | 100, 800-7212 |
Product
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
Reason for recall
Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
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-1937-2019. 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.