Recall Z-2303-2013— Radiometer America Inc
Class II · Terminated
Class II FDA medical device recall by Radiometer America Inc, initiated 2012-10-08, terminated 2013-12-24. It names 2 FDA 510(k) clearances: K043218, K002290. Product: Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.. Reason: RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane..
- Recalling firm
- Radiometer America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-08
- Terminated
- 2013-12-24
- Firm location
- Westlake, OH, United States
510(k) clearances named in this recall
2 on FDA's record- K043218 — ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
- K002290 — ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
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
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
Reason for recall
RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane.
Data sourced from openFDA. This site is unofficial and independent of the FDA.