Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas
FDA device recall Z-0608-2013 · posted 2012-12-21 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 840 Ampules
- Distribution
- Distributed to KY, NC, and NY.
- Date initiated
- 2006-06-06
- Date posted
- 2012-12-21
- Date terminated
- 2013-02-05
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUALICHECK TM (K771444) | The London Co. | 1977-08-16 |