Z-2545-2024Class II

Discrete photometric chemistry analyzer for clinical use

Name: Z-2545-2024 Discrete photometric chemistry analyzer for clinical use
Creator: Beckman Coulter, Inc.
Published: 2024-06-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-06-14 / Open, Classified

FDA source

Beckman Coulter, Inc. began a recall of Discrete photometric chemistry analyzer for clinical use on 2024-06-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2545-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-14
Posted: 2024-08-09
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Discrete photometric chemistry analyzer for clinical use.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), 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.
FDA root cause: Under Investigation by firm
Action: The recall notification was sent to consignees during the week of 06/14/2024 via email and postal mail. Consignees were instructed to follow the troubleshooting instructions in section 6.4 of the Access 2 Reference Manual and contact the Beckman Coulter representative if the laboratory has experienced repeated reagent carousel motion or QSMC errors. Consignees are asked to respond within 10 days indicating they have received the important communication either via by email or by returning the response form.
Quantity in commerce: 59 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2545-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2545-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-09

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)