Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
This recall has been terminated (originally issued December 21, 2012).
- Company
- Radiometer America Inc
- Recall Initiated
- June 6, 2006
- Posted
- December 21, 2012
- Terminated
- February 5, 2013
- Recall Number
- Z-0608-2013
- Quantity
- 840 Ampules
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed to KY, NC, and NY.
Lot / Code Info
Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
Root Cause
Process control
Action Taken
Radiometer sent Field Action Notes regarding the affected product. The note identified the product, the problem and the action to be taken by the customer. Instead of scanning the barcorde on the insert to enter the QC data into the anyalyzer, customers were instructed to manually key in the QUALICHECK type, lot number, and correct control range. For questions regarding this recall call 440-871-8900.