Reported Jun 11, 2025 · Completed
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot…
Beckman Coulter Mishima K.K.
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 Mishima K.K. · 454-32 · Sunto-Gun, N/A · N/A
Is this the product you have?
- Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
- Lot codes and dates
- DeviceREF/UDI-DI/Serial-Lot:
- AU480
B11810/14987666540664B12183/14987666540671B80091/16954701010015B96692/14987666542965B96693/14987666542972C02654/14987666543283C02655/14987666543290C02845/16954701010022C41919/14987666544174C41920/14987666544181N3659700/14987666535257N3659800/14987666535264N3659900/14987666535271N3660000/14987666535288N3660100/14987666535547N3660200/14987666535554N3660300/14987666535554N3660400/14987666535769N3660500/14987666536032N3660600/14987666536049N3660800/14987666536063N3912400/14987666537084N3912500/14987666537091N3150700N3151000N3151300N3151400N3151500N3151600
- N3151900/ SerialFrom 10155 to 2025021482
- Sample ProbeMU993400/04987666522939
- LotsFrom 178713114 to 179433670. B66751 Kits containing MU993400
- LotsFrom 178713114 to 179433670
- Amount recalled
- 10,176
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
A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.
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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