FDAFDA · Food and drugs·Recall number Z-1369-2024
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Published April 3, 2024 · Recall initiated: February 14, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories Ltd.
- Distributor
- US Nationwide distribution in the states of CA, IN.
- Lot
- GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.