Z-2545-2024 Class II Ongoing
FDA device recall Z-2545-2024 was initiated by Beckman Coulter, Inc. on Jun 14, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 59 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 21, 2024
- Initiation Date
- Jun 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 units
Product Description
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of NE, MT, LA, TX, NY, CA, MI, AL, IL the countries of Austria, Belgium, Georgia, India, Indonesia, Italy, Korea, Malaysia, Myanmar, Nigeria, Switzerland, Vietnam.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2545-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026