The ABL800 Model#:All — Class II medical device recall Z-1463-2017
Terminated recall by Radiometer America Inc, reported 2017-03-22, distributed nationwide. Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and
| Recall number | Z-1463-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Brea, CA, United States |
| Recall initiated | 2017-01-26 |
| Classified | 2017-03-14 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2018-02-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, CN, CZ, DE, DK, ES, FI, FR, HU, IN, IT, JP, NL, NO, PL, SE, SG, TR, ZA |
| Quantity | 17,522 |
| Serial numbers | 393-090R0027N001 |
Product
The ABL800 Model#:All
Reason for recall
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
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-1463-2017. 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.