Recall Z-1563-2021
Randox Laboratories Ltd. · initiated March 29, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Codes / lots: Batch / Lot number: 1162UE GTIN: 05055273200966
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.
FDA-determined 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.
Details
- Recall number
- Z-1563-2021
- Initiated
- March 29, 2021
- Terminated
- November 22, 2021
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Quantity
- 98 kits
- 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…
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North