The UniCel DxI 600 and 800 Access Immunoassay Systems — Class II medical device recall Z-1077-2019
Ongoing recall by Beckman Coulter Inc., reported 2019-04-10, distributed in AK, AL, CA, DC, FL, GA, ID, IL…. When racks are front-loaded onto the sample presentation unit while samples from the automation line are being
| Recall number | Z-1077-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-12-05 |
| Classified | 2019-03-30 |
| Reported by FDA | 2019-04-10 |
| Distributed | AK, AL, CA, DC, FL, GA, ID, IL, IN, KY, LA, MA, MI, MN, MS, NC, ND, NJ, NY, OH, PA, TN, TX, WA, WI, WV |
| Countries outside the US | AR, AU, BH, CA, CH, CN, CZ, DE, EG, ES, GB, GR, HR, IN, IT, MA, MY, NG, NL, PL, PT, QA, SA, SG, TH, TN, VN, ZA |
| Quantity | 2,842 |
| Reason classes | software |
| Serial numbers | 600335, 600742, 600873, 601051, 601057, 601096, 601142, 601196, 601245, 601256, 601259, 601298, 601312, 601333, 601346, 601371, 601418, 601464, 601473, 601547, 601596, 601600, 601607, 601697, 601707 and 475 more |
| Model numbers | 973100, A25285, A25288, A30260, A71456, A71457, A71460, A71461, A84545, A92060 |
Product
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
Reason for recall
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
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-1077-2019. 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.