FDA Device recall Z-0608-2013
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042
- FDA Device
- Class III
- terminated
- Published 2013-01-02
On 2013-01-02 the FDA classified a Class III recall of Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042 by Radiometer America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0608-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2006-06-06 |
| Published | 2013-01-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Radiometer America |
| Distribution | KY, NC, NY |
Product
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Reason
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.
Identifiers
| code_info | Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Radiometer America
- ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
FDA Device · Class II · 2019-08-28 · Radiometer America - Product: ABL800 FLEX with Crea
FDA Device · Class II · 2019-02-13 · Radiometer America - ABL800 analyzer, model numbers 393-800 and 393-801
FDA Device · Class II · 2019-01-02 · Radiometer America - ABL90 FLEX analyzers with software versions 3.3MR1 or below
FDA Device · Class II · 2018-10-10 · Radiometer America - ABL800 analyzer with FLEXQ module
FDA Device · Class II · 2017-12-20 · Radiometer America
All Radiometer America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0608-2013%22
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