Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for...
FDA Recall #Z-0608-2013 — Class III — June 6, 2006
Product Description
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
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.
Recalling Firm
Radiometer America Inc — Westlake, OH
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
840 Ampules
Distribution
Distributed to KY, NC, and NY.
Code Information
Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated