Radiometer Qualicheck 1+ Quality Control Solution Recalled for Barcode Error
Radiometer America Inc is recalling Qualicheck 1+ quality control solution due to a barcode error that incorrectly enters a pH control range into blood gas analyzers.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/barcode error affecting quality control ranges, not a direct patient safety hazard.
Plain-English summary
Radiometer America Inc is recalling Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The product is a solution used for quality checks of blood gas analyzers. The recall involves 840 ampules from Lot R0040 (expiration date February 2008) and Lot R0042 (expiration date April 2008).
The recall was initiated because 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. This discrepancy could lead to incorrect quality control readings.
The product was distributed to Kentucky, North Carolina, and New York. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
- Manufacturer
- Radiometer America Inc
- Hazard
- Affected units
- 840
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot R0040
- expiration date February 2008
- Lot R0042
- expiration date April 2008.
Distribution
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