iChem 10 SG Urine Chemistry Strips — Class II medical device recall Z-0649-2016
Terminated recall by Beckman Coulter Inc., reported 2016-01-20, distributed in PR. Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte resu
| Recall number | Z-0649-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2014-12-08 |
| Classified | 2016-01-13 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-01-13 |
| Distributed | PR |
| Countries outside the US | AE, BR, CA, CH, CL, DE, EC, ES, FR, GR, IT, KW, LU, MY, PH, PT, SG, TR |
Product
iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
Reason for recall
Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
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-0649-2016. 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.