Reported Jan 2, 2013 · Terminated
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood…
Radiometer America Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer America Inc · 810 Sharon Dr · Westlake, OH · 44145-1598
Is this the product you have?
- Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
- Lot codes and dates
Lot R0040expiration date February 2008Lot R0042expiration date April 2008
- Amount recalled
- 840 Ampules
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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