FDA Device recall Z-2637-2017
Access System-Free T4 Assay, B01902E, Catalog No. 33880
- FDA Device
- Class II
- terminated
- Published 2017-07-05
On 2017-07-05 the FDA classified a Class II recall of Access System-Free T4 Assay, B01902E, Catalog No. 33880 by Beckman Coulter, citing the Access immunoassays are susceptible to biotin interference.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2637-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-09 |
| Published | 2017-07-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | GA, PR |
Product
Access System-Free T4 Assay, B01902E, Catalog No. 33880
Reason
The Access immunoassays are susceptible to biotin interference.
Identifiers
| code_info | all 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-2637-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.