Food, drugs, devices › Radiometer America Inc

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

FDA enforcement event 37530 · Class III · initiated 6 Jun 2006 · status Terminated · terminated 5 Feb 2013

DeviceVoluntary: Firm initiated1 product recordWestlake, OH

FDA enforcement event 37530 is a device recall by Radiometer America Inc of Westlake, OH, initiated 6 Jun 2006 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 10% of the 10 device enforcement events initiated in 2006 carry the same class.

Status: Terminated, terminated 5 Feb 2013. Initiation: voluntary: firm initiated. Radiometer America Inc has 22 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Radiometer America Inc, Westlake, OH.

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."

Distribution

"Distributed to KY, NC, and NY."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0608-2013	Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.	840 Ampules	Class III	Terminated	2 Jan 2013

Context

10%of 2006 device events are Class III10 events that year

1product record in this eventfirm median: 1

22events on this register for the firm

Other enforcement events for Radiometer America Inc

Initiated	Product (first record)	Type	Class	Records
10 Jul 2019	ABL90 FLEX Analyzer REF 393090 UDI:05700693930909	Device	Class II	1
3 Jul 2018	ABL800 analyzer, model numbers 393-800 and 393-801.	Device	Class II	1
2 Jul 2018	Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and AB	Device	Class II	1
25 May 2018	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer t	Device	Class II	1
24 Oct 2017	ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO	Device	Class II	1
7 Sep 2017	AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control	Device	Class II	1
26 Jan 2017	ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate,	Device	Class II	2
23 Nov 2016	AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE	Device	Class II	1
29 Dec 2015	AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.	Device	Class II	1
18 Nov 2015	TCM CombiM Modules 903-111	Device	Class II	1

All 22 events for Radiometer America Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall 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."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed to KY, NC, and NY."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 5 Feb 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.