Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
This recall has been terminated (originally issued March 29, 2021).
- Recall Initiated
- March 29, 2021
- Terminated
- November 22, 2021
- Recall Number
- Z-1563-2021
- Quantity
- 98 kits
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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.
Lot / Code Info
Batch / Lot number: 1162UE GTIN: 05055273200966
Root Cause
Nonconforming Material/Component
Action Taken
On 03/29/2021, Randox issued an Urgent Medical Device Correction notice to customer via letter notifying them, Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator Calibration Serum Level 3. Action to be taken: -Discuss the contents of this notice with your Medical Director. -Complete and return the response form 12187-QA to technical.services@ randox.com within five working days. For questions or concerns contact Randox Technical Services.