ABL90 FLEX Analyzer Radiometer Medical ApS — Class II medical device recall Z-0816-2014
Terminated recall by Radiometer America Inc, reported 2014-01-29, distributed in AL, AZ, CA, CO, CT, DC, FL, GA…. RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium
| Recall number | Z-0816-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Westlake, OH, United States |
| Recall initiated | 2013-10-15 |
| Classified | 2014-01-23 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-06-19 |
| Distributed | AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AT, AU, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HU, IT, JP, NL, NO, PL, RU, SE, SG, TR, ZA |
| Lot numbers | R0375N009 |
| Model numbers | 393-090, 393-090R0027N001, 393-090R0379N010 |
Product
ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Reason for recall
RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
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-0816-2014. 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.