Beckman Coulter ACCESS Immunoassay Systems — Class II medical device recall Z-2240-2020
Terminated recall by Beckman Coulter Inc., reported 2020-06-10, distributed in AK, AL, AR, AS, AZ, CA, CO, CT…. The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all bioti
| Recall number | Z-2240-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2019-04-30 |
| Classified | 2020-06-02 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2021-12-28 |
| Distributed | AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CR, CW, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, GY, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KE, KR, KW, LB, LK, LT, MA, MX, MY, NG, NL, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SE, SG, SK, SV, TH, TN, TR, TW, UY, VE, VN, ZA |
| Quantity | 95,453 units |
| UPC / GTIN / UDI-DI | 15099590227173 |
| Model numbers | 33860 |
Product
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.
Reason for recall
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays (Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
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-2240-2020. 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.