AutoCheck5+ — Class II medical device recall Z-3237-2017
Terminated recall by Radiometer America Inc, reported 2017-10-11, distributed nationwide. Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect resu
| Recall number | Z-3237-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Brea, CA, United States |
| Recall initiated | 2017-09-07 |
| Classified | 2017-09-29 |
| Reported by FDA | 2017-10-11 |
| Terminated | 2019-08-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HU, IN, IT, KR, NL, NO, PL, SE, SG, TR, ZA |
| Quantity | 1,669 boxes |
| Lot numbers | R0698 |
Product
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
Reason for recall
Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92 5.85 kPa or 36.9 46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)
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-3237-2017. 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.