Z-3237-2017Class II

AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+...

Name: Z-3237-2017 AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+...
Creator: Radiometer America Inc
Published: 2017-09-07
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2017-09-07 / Terminated

FDA source

Radiometer America Inc began a recall of AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed... on 2017-09-07. FDA classified it as Class II and gives the reason as "Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3237-2017
Classification: Class II
Status: Terminated
Initiated: 2017-09-07
Posted: 2017-09-29
Terminated: 2019-08-01
Recalling firm: Radiometer America, Inc
Product: AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
Product code: JJS Controls For Blood-Gases, (Assayed And Unassayed)
Reason for recall: Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92 5.85 kPa or 36.9 46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)
FDA root cause: Under Investigation by firm
Action: Radiometer sent a Safety Notice dated September 7, 2017, to all affected customers. The firm initiated their recall on 09/07/2017 by email. The letter requested the following: 1. Please check your inventory and analyzers for any boxes and ampoules of above mentioned QC. 2. Discard all Boxes and ampoules of this lot. 3. Complete the response form and return it to the number on the form. Please note: If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-user. Customers with questions were advised to contact their Radiometer representative.
Quantity in commerce: 1669 Boxes
Distribution: Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland.
Product codes and lots: S7745 Lot R0698

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3237-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3237-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-11	2017-09-29

Product code JJS

K980135Class IQualicheck5+ Models S7730, S7740, S7750, S7760Radiometer America, Inc. / cleared 1998-01-28

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)