Recall Z-0660-2019
Randox Laboratories Ltd. · initiated November 19, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Codes / lots: 05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019
Reason for recall
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
FDA-determined cause: Under Investigation by firm
Action taken
On November 19, 2018, Randox Laboratories Ltd. issued "Urgent Medical Device Correction" notices and New Calibrator Value sheets (Revised 15 Nov 18 pl) to customers. Customers were advised to take the following action: - Review all remaining stock. Add the notice and replace the calibrator value sheet with the revised document provided. - Discuss the contents of the notice with your Medical Director. Review results generated with the affected batches in line with the clinical profile of the patient. - Retain a copy of the letter with laboratory records and forward a copy of the letter to those who may have received this product. - Return the completed response form via email to technical.services@randox.com. If you have any questions, contact RA Specialist by email at maria.kelly@randox.com.
Details
- Recall number
- Z-0660-2019
- Initiated
- November 19, 2018
- Terminated
- April 23, 2020
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Quantity
- 250 kits (32 kits US / 218 kits OUS)
- Distribution
- US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North