ABL90 FLEX analyzer — Class II medical device recall Z-1046-2015
Terminated recall by Radiometer America Inc, reported 2015-02-11, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can
| Recall number | Z-1046-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Westlake, OH, United States |
| Recall initiated | 2014-12-08 |
| Classified | 2015-02-03 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2015-09-23 |
| Distributed | AL, AR, AZ, CA, CO, CT, 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 | AE, AT, AU, BO, BR, CA, CH, CN, CZ, DE, DK, EE, ES, FI, FR, GB, HK, HU, ID, IE, IL, IT, JP, KR, KW, LT, MX, MY, NL, NO, NZ, PE, PL, QA, RO, RS, RU, SA, SE, SG, SI, TH, TR, TW, VN, ZA |
| Quantity | 5,002 units |
| Serial numbers | 393-090R0027N001 |
| Model numbers | 393-090 |
Product
ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Reason for recall
The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.
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-1046-2015. 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.