FDAFDA · Food and drugs·Recall number Z-2021-2023
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
Published July 5, 2023 · Recall initiated: May 4, 2023
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
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories Ltd.
- Distributor
- CA, IL, VA, WA, WI including PR
- Lot
- GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- Ireland
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