N Latex HCY REAGENT — Class II medical device recall Z-1227-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2017-03-01, distributed nationwide. The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 8029
| Recall number | Z-1227-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2017-01-11 |
| Classified | 2017-02-21 |
| Reported by FDA | 2017-03-01 |
| Terminated | 2018-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BR, CH, CL, CN, CZ, DE, ES, FR, GB, IT, KW, LV, PL, SA, TR |
| Reason classes | specification failure |
| Lot numbers | 802907632 |
| Model numbers | 10445973, OPAX03 |
| Expiration dates | 2017-02-13 |
Product
N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Reason for recall
The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.
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-1227-2017. 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.