FDAFDA · Food and drugs·Recall number Z-1759-2024
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Published May 15, 2024 · Recall initiated: March 5, 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
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories Ltd.
- Distributor
- Domestic: Nationwide Distribution.
- Lot
- Catalogue No. CAL2351 & CAL10388; GTIN: 05055273200966; Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.