The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1907-2025·Announced 2025-06-11

Beckman Coulter Sample Probe Manufacturing Defect Recall

Beckman Coulter Mishima is recalling sample probes due to a manufacturing defect where rounded and chamfered corners prevent proper air layer formation, causing sample dilution and inaccurate test results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. No reported illnesses, injuries, or deaths are mentioned in the source. The hazard involves inaccurate measurement output rather than direct physical injury, and the source text contains no evidence of actual harm. This fits the Moderate criteria for Class II recalls without reported adverse outcomes.

Plain-English summary

Beckman Coulter Mishima K.K. is recalling sample probes (model MU993400) distributed worldwide, including nationwide across the United States and to numerous countries. The defective probes have rounded and chamfered corners on the tip that prevent proper formation of the air layer—the air space that normally separates cleaning water from the sample during dispensing.

In affected probes, the air layer does not form properly, allowing cleaning water and sample to mix. This dilution causes the sample placed into the cuvette to have a lower concentration than the original sample, resulting in measured analyte concentrations that are lower than expected.

Affected units include sample probes with lot numbers ranging from 178713114 to 179433670, and B66751 kits containing these probes with the same lot range. The device is used in laboratory testing equipment from Beckman Coulter. Customers who have received affected devices should contact Beckman Coulter Mishima K.K. for replacement or further guidance.

The recalled product

Product
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Manufacturer
Beckman Coulter Mishima K.K.
Category
Medical Device — Laboratory Testing Equipment Component
Hazard
Affected units
10,176

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Device: REF/UDI-DI/Serial-Lot: AU480: B11810/14987666540664
  • B12183/14987666540671
  • B80091/16954701010015
  • B96692/14987666542965
  • B96693/14987666542972
  • C02654/14987666543283
  • C02655/14987666543290
  • C02845/16954701010022
  • C41919/14987666544174
  • C41920/14987666544181
  • N3659700/14987666535257
  • N3659800/14987666535264
  • N3659900/14987666535271
  • N3660000/14987666535288
  • N3660100/14987666535547
  • N3660200/14987666535554
  • N3660300/14987666535554
  • N3660400/14987666535769
  • N3660500/14987666536032
  • N3660600/14987666536049

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Beckman Coulter Mishima K.K. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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