uTASWako DCP — Class II medical device recall Z-1831-2013
Terminated recall by Wako Life Sciences, Inc., reported 2013-08-07, distributed in CA, DC, GA, MN, NC, UT. Product fails to meet the accuracy at the low end of the measuring range.
| Recall number | Z-1831-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wako Life Sciences, Inc., Mountain View, CA, United States |
| Recall initiated | 2013-04-30 |
| Classified | 2013-07-30 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2013-08-19 |
| Distributed | CA, DC, GA, MN, NC, UT |
| Lot numbers | 2013.11, TG340 |
| Model numbers | 995-60701 |
| Expiration dates | 2013-11-30 |
Product
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
Reason for recall
Product fails to meet the accuracy at the low end of the measuring range.
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-1831-2013. 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.