Access BR Monitor — Class II medical device recall Z-2074-2017
Terminated recall by Beckman Coulter Inc., reported 2017-05-24, distributed in GA, GU, PR. Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been inf
| Recall number | Z-2074-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-04-13 |
| Classified | 2017-05-12 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2018-06-04 |
| Distributed | GA, GU, PR |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DZ, EC, EG, ES, FR, GB, GH, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KE, KR, LB, LT, MA, MX, MY, NG, NL, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SG, SK, SV, TH, TR, TW, VE, VN, ZA |
| Model numbers | 387620 |
Product
Access BR Monitor, Part No. 387620
Reason for recall
Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de s¿curit¿ du Medicament et des produits de sant¿ (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).
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-2074-2017. 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.