FDA Device recall Z-2074-2017
Access BR Monitor, Part No. 387620
- FDA Device
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of Access BR Monitor, Part No. 387620 by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2074-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-13 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | GA, PR |
Product
Access BR Monitor, Part No. 387620
Reason
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).
Identifiers
| code_info | 623913, 625701, 628771, 630349, 633070 and All Future Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2074-2017%22
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