FDA Device recall Z-2108-2016
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative…
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative… by Beckman Coulter, citing demonstrate an upward shift in patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2108-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-08 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | PR |
Product
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
Reason
Demonstrate an upward shift in patient results.
Identifiers
| code_info | 524087 526807 528874 529913 530102 531647 532473 534080 534081 534336 535481 570090 570116 570222 570236…524087 526807 528874 529913 530102 531647 532473 534080 534081 534336 535481 570090 570116 570222 570236 570239 570245 570246 622173 622174 671016 671025 671033 |
|---|
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-2108-2016%22
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