Device product
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Z-1563-2021
Product summary
- Event
- Event 87765
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98 kits
- Official record key
device-enforcement:Z-1563-2021
Official wording
Reason: Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.
Code information: Batch / Lot number: 1162UE GTIN: 05055273200966
Distribution pattern: Domestic: IN, MA, CA, NJ, TX, NE, NY, VA, MD, MN, OR, IL, CT, DC, MS. Foreign: Albania, Argentina, Australia, Bangladesh, Bolivia, Bosnia & Herzegovina, Cameroon, Canada, Colombia, Cyprus, Denmark, Egypt, Estonia, Fiji, France, Germany, Greece, Hong Kong, Iraq, Italy, Ireland, Jordan, Kazakhstan, Kenya, Lithuania, Luxembourg, Mauritius, Mexico, Myanmar, Nepal, New Zealand, Pakistan, Palestine, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Thailand, The Netherlands, Turkey, UK, Ukraine, USA, and Vietnam.
Derived failure modes
-
Unknown
Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.