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:
- AU680
B12185/14987666540732B12186/14987666540688B12187/14987666540701B12188/14987666540725B96694/14987666542989B96695/14987666542996B96696/14987666543009C02656/14987666543306C02657/14987666543313N3147700/15099590346249N3662000/14987666535301N3662100/14987666535318N3662200/14987666535325N3662700/14987666535615N3663000/14987666535646N3910200/14987666535790N3910400/14987666535813N3910500/14987666535820N3910600/14987666535912N3910800/14987666535936N3910900/4987666535946N3911200/14987666535974N3911700/14987666536575N3911900/14987666536599N3147100N3147200N3147300N3147400N3147600N3148100N3149400N3149800
- SerialFrom 10436 to 2022087656
- Sample ProbeMU993400/04987666522939
- LotsFrom 178713114 to 179433670. B66752 Kits containing MU993400
- LotsFrom 178713114 to 179433670
- Amount recalled
- 6,166
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
Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.
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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