Device product
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Z-0608-2013
Product summary
- Event
- Event 37530
- Status
- Terminated
- Classification
- Class III
- Quantity
- 840 Ampules
- Official record key
device-enforcement:Z-0608-2013
Official wording
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.
Code information: Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
Distribution pattern: Distributed to KY, NC, and NY.
Derived failure modes
-
Unknown
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.