Recall Z-0457-2009
Radiometer America Inc · initiated September 5, 2008
Product
ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb, FHbF). Also, intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2.
Codes / lots: P/N S1720, 944-024; Lot: WA-04
Reason for recall
The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the calibration curves for these parameters and thereby the measured results for patient samples and quality controls will be biased.
FDA-determined cause: Process control
Action taken
On, 9/2/2008 the firm sent out recall notification letters requesting their customers discard any Calibration 1 Solution (CAL1) S1720 (part number 944-024), lot WA-04, complete the attached return form and fax it to 800-736-0601. The firm will send out replacements for all affected product that the firm shows was shipped to their location. Further questions could be directed to Technical Support at 800-736-0600, option 2.
Details
- Recall number
- Z-0457-2009
- Initiated
- September 5, 2008
- Posted by FDA
- December 3, 2008
- Terminated
- April 25, 2012
- Product code
- JFP – Electrode, Ion Specific, Calcium
- Quantity
- 3,200/200ml bottles
- Distribution
- Worldwide Distribution --- USA including states of AZ, CA, FL, IA, ID, IL, IN, KY, LA, MD, NC, ND, NE, NY, OH, OK, PA, SD, TX, VA, WA, and WI, and country of Canada.
- Recalling firm
- Radiometer America Inc, Westlake, OH