Recall Z-0608-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
| Date | Dec 21, 2012 (initiated Jun 6, 2006) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K771444 | QUALICHECK TM The London Co., Aug 16, 1977 |