Qualicheck 1+ recall
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Why was Qualicheck 1+ recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
- Product
- Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
- Recalling firm
- Radiometer America Inc
- Quantity
- 840 Ampules
- Distribution
- Distributed to KY, NC, and NY.
- Recall date
- January 2, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)