CLASS III Device recall · Reported 2 Jan 2013 · FDA Enforcement Report

Qualicheck 1+, Aqueous Quality Control, Level 2, S7140 recalled

Radiometer America is recalling Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, distributed in Kentucky, North Carolina, New York. The recall was initiated on 6 Jun 2006 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.

Quantity recalled840 Ampules

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0608-2013
FDA event ID: 37530
Recalling firm: Radiometer America, Westlake, OH
Classification: Class III
Status: Terminated
Recall initiated: 6 Jun 2006
FDA classified: 21 Dec 2012
Reported: 2 Jan 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

6 Jun 2006	Recall initiated by company
21 Dec 2012	Classified by FDA	+2390 days
2 Jan 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.

Where it was distributed

Distributed to KY, NC, and NY.

Kentucky North Carolina New York

Questions about this recall

Why was it 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.

Which lots are affected?

Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.

Where was it sold?

Distributed to KY, NC, and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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