Sample probe sucks a sample dispensed into a tube or cup and… — Class II medical device recall Z-1907-2025
Completed recall by Beckman Coulter Mishima K.K., reported 2025-06-11, distributed nationwide. A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are roun
| Recall number | Z-1907-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Mishima K.K., Sunto-Gun, N/A, Japan |
| Recall initiated | 2025-04-30 |
| Classified | 2025-06-04 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CW, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GH, GR, GY, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KE, KR, KW, LB, LK, LT, MA, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 10,176 |
| UPC / GTIN / UDI-DI | 04987666522939, 14987666535257, 14987666535264, 14987666535271, 14987666535288, 14987666535547, 14987666535554, 14987666535769, 14987666536032, 14987666536049, 14987666536063, 14987666537084, 14987666537091, 14987666540664, 14987666540671, 14987666542965, 14987666542972, 14987666543283, 14987666543290, 14987666544174, 14987666544181, 16954701010015, 16954701010022 |
| Lot numbers | 178713114, 179433670, AU480, B11810/14987666540664, B12183/14987666540671, B80091/16954701010015, B96692/14987666542965, B96693/14987666542972, C02654/14987666543283, C02655/14987666543290, C02845/16954701010022, C41919/14987666544174, C41920/14987666544181, N3150700, N3151000, N3151300, N3151400, N3151500, N3151600, N3151900, N3659700/14987666535257, N3659800/14987666535264, N3659900/14987666535271, N3660000/14987666535288, N3660100/14987666535547, N3660200/14987666535554, N3660300/14987666535554, N3660400/14987666535769, N3660500/14987666536032, N3660600/14987666536049, N3660800/14987666536063, N3912400/14987666537084, N3912500/14987666537091 |
Product
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1907-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.