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 Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems
This recall has been terminated (originally issued August 9, 2019).
- Recall Initiated
- August 9, 2019
- Terminated
- January 8, 2021
- Recall Number
- Z-0283-2020
- Quantity
- 100 kits
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico.
Lot / Code Info
Batch/Lot # 440973 /1748 1752IT 451414 /1748 1752IT 470531 /1813 1817IT 480859 /1813 1817IT
Root Cause
Nonconforming Material/Component
Action Taken
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.