FDAFDA · Food and drugs·Recall number Z-0608-2013
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Published January 2, 2013 · Recall initiated: June 6, 2006
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Radiometer America Inc
- Distributor
- Distributed to KY, NC, and NY.
- Lot
- Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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