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 R0040
    • expiration date February 2008
    • Lot R0042
    • expiration 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 5, 2013 · Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.