Recall Z-0283-2020 ยท JIX Calibrator, Multi-Analyte Mixture
Randox Laboratories Ltd.
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Archite
| Date | Aug 9, 2019 |
| Status | Terminated |
| Reason | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material. |
| Root cause | Nonconforming Material/Component |
| Action | 1. Review your reagent inventory and replace the value sheet with the new values provided. 2. Review results generated with the affected batches in line with the clinical profile of the patient. 3. Discuss the contents of this notice with your Medical Director. 4. Complete and return the response form 12187-QA to teclhnical.services@randox.com within five working days. |
| Quantity | 100 kits |
| Distribution | US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061056 | RANDOX LIQUID PROTEIN CALIBRATOR Randox Laboratories, Ltd., Jul 20, 2006 |