Access Ostase QC — Class II medical device recall Z-0408-2017
Terminated recall by Beckman Coulter Inc., reported 2016-11-23, distributed nationwide. Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their e
| Recall number | Z-0408-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2016-10-24 |
| Classified | 2016-11-14 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2018-02-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CH, CN, CZ, DE, ES, FR, GR, HK, HU, IN, IT, JP, KR, MX, PH, PT, RO, RS, SG, SK, TW, ZA |
| Model numbers | 37309, B83877 |
Product
Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
Reason for recall
Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.
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-0408-2017. 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.