Immunoassay Premium Level 3-In vitro diagnostic use recall
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes.…
Why was Immunoassay Premium Level 3-In vitro diagnostic use recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23
- Product
- Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes.…
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 1 kit
- Distribution
- CA, IL, VA, WA, WI including PR
- Recall date
- July 5, 2023
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)