Reported Aug 21, 2024 · Ongoing
Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
- Discrete photometric chemistry analyzer for clinical use.
- Lot codes and dates
- Catalog Number
81600NC11907
- UDI150995901
- Serial Numbers
574415574440574484574416574441574485574417574442574486574418574443574488574419574444574489574420574445574490574421574446574491574422574447 574494574423574448574497574424574454574502574425574455574503574426574456 574504574427574457574505574428574459574506574429574469574507574430574470 574509574432574471574513574433574472574514574434574477574515574435574479
- Catalog Number
- Amount recalled
- 59 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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