FDA Device recall Z-1046-2015
ABL90 FLEX analyzer
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of ABL90 FLEX analyzer by Radiometer America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1046-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-08 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Radiometer America |
| Distribution | 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 |
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
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.
Identifiers
| code_info | Model number 393-090 (instrument). The affected analyzers are serial numbers 393-090R0027N001 to present. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Radiometer America
- ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
FDA Device · Class II · 2019-08-28 · Radiometer America - Product: ABL800 FLEX with Crea
FDA Device · Class II · 2019-02-13 · Radiometer America - ABL800 analyzer, model numbers 393-800 and 393-801
FDA Device · Class II · 2019-01-02 · Radiometer America - ABL90 FLEX analyzers with software versions 3.3MR1 or below
FDA Device · Class II · 2018-10-10 · Radiometer America - ABL800 analyzer with FLEXQ module
FDA Device · Class II · 2017-12-20 · Radiometer America
All Radiometer America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1046-2015%22
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