ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 — Class II medical device recall Z-1321-2022
Ongoing recall by Radiometer Medical ApS, reported 2022-07-13, distributed nationwide. There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured wi
| Recall number | Z-1321-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2022-05-18 |
| Classified | 2022-07-01 |
| Reported by FDA | 2022-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BG, BH, BM, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IL, IN, IQ, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, MT, MX, MY, NG, NI, NO, NP, NZ, OM, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 1,489 analyzers |
| UPC / GTIN / UDI-DI | 05700693938004, 05700693938011 |
| Model numbers | 393-800, 393-801 |
Product
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Reason for recall
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
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-1321-2022. 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.