Access Immunoassay Systems — Class II medical device recall Z-1257-2023
Ongoing recall by Beckman Coulter, Inc., reported 2023-03-22, distributed nationwide. An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of
| Recall number | Z-1257-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2023-01-26 |
| Classified | 2023-03-15 |
| Reported by FDA | 2023-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CW, CZ, DE, DO, DZ, EC, EG, ES, FR, GB, GH, GR, GY, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, LK, LT, MA, MX, MY, NG, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, UY, VN, ZA |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 15099590265380 |
| Serial numbers | 386220, 500675, 501192, 501325, 501446, 501647, 501922, 502049, 502132, 502245, 502294, 502365, 502421, 502437, 502656, 502676, 502742, 502907, 502968, 502977, 503059, 503083, 503097, 503137, 503141 and 475 more |
| Model numbers | 81600N, A25640 |
Product
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
Reason for recall
An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a remote probability of delayed results or reporting erroneous patient results. The subject nut bands were found to not meet the firm's specifications for hardness and had the incorrect material grain direction. Affected instruments were manufactured from December 28, 2017 to October 19, 2022 or had their nut bands replaced during the same period.
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-1257-2023. 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.