Discrete photometric chemistry analyzer for clinical use — Class II medical device recall Z-2545-2024
Ongoing recall by Beckman Coulter, Inc., reported 2024-08-21, distributed nationwide. Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System A
| Recall number | Z-2545-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-06-14 |
| Classified | 2024-08-09 |
| Reported by FDA | 2024-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, ID, IN, IT, KR, MY, NG, VN |
| Quantity | 59 units |
| Serial numbers | 574415, 574416, 574417, 574418, 574419, 574420, 574421, 574422, 574423, 574424, 574425, 574426, 574427, 574428, 574429, 574430, 574432, 574433, 574434, 574435, 574440, 574441, 574442, 574443, 574444 and 34 more |
| Model numbers | 81600N, C11907 |
Product
Discrete photometric chemistry analyzer for clinical use.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.