FDA Medical Device Recalls (openFDA)
Radiometer America Inc: Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
- Recall number
- Z-0608-2013
- Recalling firm
- Radiometer America Inc
- Product
- Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
- Status
- Terminated
- Initiated
- 2006-06-06
- Posted
- 2012-12-21
- Terminated
- 2013-02-05
- 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.
- Root cause
- Process control
- Action
- Radiometer sent Field Action Notes regarding the affected product. The note identified the product, the problem and the action to be taken by the customer. Instead of scanning the barcorde on the insert to enter the QC data into the anyalyzer, customers were instructed to manually key in the QUALICHECK type, lot number, and correct control range. For questions regarding this recall call 440-871-8900.
- Quantity
- 840 Ampules
- Distribution
- Distributed to KY, NC, and NY.
- Lot, serial or model codes
- Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
- 510(k) numbers
- ["K771444"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28