FDA Device recall Z-2545-2024
Discrete photometric chemistry analyzer for clinical use
- FDA Device
- Class II
- ongoing
- Published 2024-08-21
On 2024-08-21 the FDA classified a Class II recall of Discrete photometric chemistry analyzer for clinical use by Beckman Coulter, citing beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2545-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-14 |
| Published | 2024-08-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Discrete photometric chemistry analyzer for clinical use.
Reason
Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module. Customers affected by this issue may observe an increase in reagent carousel motion errors or QSMC errors that occur while unloading or loading reagent packs during system initialization and sample processing, which causes a non-operational system status and cancels tests; and patient results may be delayed if these errors cancel test processing.
Identifiers
| code_info | Catalog Number: 81600N, C11907; UDI: 150995901; Serial Numbers: 574415, 574440, 574484,574416, 574441, 574485, 574417,…Catalog Number: 81600N, C11907; UDI: 150995901; Serial Numbers: 574415, 574440, 574484,574416, 574441, 574485, 574417, 574442, 574486, 574418, 574443, 574488,574419, 574444, 574489,574420, 574445, 574490, 574421, 574446, 574491, 574422, 574447 574494,574423, 574448, 574497,574424, 574454, 574502, 574425, 574455, 574503, 574426, 574456 574504,574427, 574457, 574505,574428, 574459, 574506, 574429, 574469, 574507, 574430, 574470 574509,574432, 574471, 574513, 574433, 574472, 574514, 574434, 574477, 574515, 574435, 574479 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2545-2024%22
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