Recall Z-0748-2016— Radiometer America Inc
Class II · Terminated
Class II FDA medical device recall by Radiometer America Inc, initiated 2015-12-29, terminated 2016-03-29. It names 3 FDA 510(k) clearances: K151856, K142898, K130144. Product: AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.. Reason: The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results..
- Recalling firm
- Radiometer America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-29
- Terminated
- 2016-03-29
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K151856 — ABL80 FLEX CO-OX with AQURE connectivity
- K142898 — ABL800 FLEX with AQURE connectivity
- K130144 — ABL90 FLEX
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Reason for recall
The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.