Recall Z-0608-2013— Radiometer America Inc
Class III · Terminated
Class III FDA medical device recall by Radiometer America Inc, initiated 2006-06-06, terminated 2013-02-05. It names one FDA 510(k) clearance: K771444. Product: Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.. Reason: The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45..
- Recalling firm
- Radiometer America Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2006-06-06
- Terminated
- 2013-02-05
- Firm location
- Westlake, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Reason for recall
The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.
Data sourced from openFDA. This site is unofficial and independent of the FDA.