Sample probe sucks a sample dispensed into a tube or cup and… — Class II medical device recall Z-1908-2025
Completed recall by Beckman Coulter Mishima K.K., reported 2025-06-11, distributed nationwide. Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower conc
| Recall number | Z-1908-2025 |
|---|---|
| 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 | 6,166 |
| UPC / GTIN / UDI-DI | 04987666522939, 04987666535946, 14987666535301, 14987666535318, 14987666535325, 14987666535615, 14987666535646, 14987666535790, 14987666535813, 14987666535820, 14987666535912, 14987666535936, 14987666535974, 14987666536575, 14987666536599, 14987666540688, 14987666540701, 14987666540725, 14987666540732, 14987666542989, 14987666542996, 14987666543009, 14987666543306, 14987666543313, 15099590346249 |
| Lot numbers | 178713114, 179433670, AU680, B12185/14987666540732, B12186/14987666540688, B12187/14987666540701, B12188/14987666540725, B96694/14987666542989, B96695/14987666542996, B96696/14987666543009, C02656/14987666543306, C02657/14987666543313, N3147100, N3147200, N3147300, N3147400, N3147600, N3147700/15099590346249, N3148100, N3149400, N3149800, N3662000/14987666535301, N3662100/14987666535318, N3662200/14987666535325, N3662700/14987666535615, N3663000/14987666535646, N3910200/14987666535790, N3910400/14987666535813, N3910500/14987666535820, N3910600/14987666535912, N3910800/14987666535936, N3910900/4987666535946, N3911200/14987666535974, N3911700/14987666536575, N3911900/14987666536599 |
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
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.
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-1908-2025. 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.