FDAFDA · Food and drugs·Recall number Z-2557-2019
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
Published October 2, 2019 · Recall initiated: July 25, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories Ltd.
- Distributor
- US Nationwide distribution including the states of IN, WV.
- Lot
- Lot: 1020UC Exp. Date: 28 May 2020
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- Ireland
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.