FDA Device recall Z-0239-2016
Access CEA Assay, Part No. 33200
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of Access CEA Assay, Part No. 33200 by Beckman Coulter, citing beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0239-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-13 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Reason
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
Identifiers
| code_info | 595027 595029 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0239-2016%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.