FDA Device recall Z-2733-2015
Access Thyroglobulin Assay
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of Access Thyroglobulin Assay by Beckman Coulter, citing beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2733-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-28 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
Reason
Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL.
Identifiers
| code_info | Catalogue number: 33860 Lot numbers: 431990 434727 430969 522896 523251 Expiration date: 10/31/16 12/31/16 08/31/16 04/30/17 05/31/17 |
|---|
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-2733-2015%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.