Z-0608-2013Class III

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

Name: Z-0608-2013 Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check...
Creator: Radiometer America Inc
Published: 2006-06-06
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2006-06-06 / Terminated / root cause: manufacturing process

FDA source

Radiometer America Inc began a recall of Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers on 2006-06-06. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0608-2013
Classification: Class III
Status: Terminated
Initiated: 2006-06-06
Posted: 2012-12-21
Terminated: 2013-02-05
Recalling firm: Radiometer America, Inc
Product: Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 840 Ampules
Distribution: Distributed to KY, NC, and NY.
Product codes and lots: Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0608-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0608-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-02	2012-12-21

Product code JJE

K771444Class IQualicheck TmThe London Co. / cleared 1977-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)