QuikLYTE Dilution Check: used to monitor and adjust for recall
QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended…
Why was QuikLYTE Dilution Check: used to monitor and adjust for recalled?
A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. The dilution check correction would be detected by QC; however, if not detected by QC, the calibration curve would be decreased and cause elevated sodium, potassium and chloride patient results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number S640, Siemens Material Number (SMN) 10444872, Lot Number 4MD707
- Product
- QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 5981
- Distribution
- Worldwide Distribution.
- Recall date
- April 15, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)