Immunoassay Premium Controls recall
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
Why was Immunoassay Premium Controls recalled?
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Catalog numbers: IA2633 (Lots: 398703, 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC, 1516EC, 1626EC) IA2640 (Lots 1517EC, 1668EC)
- Product
- Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
- Recalling firm
- Randox Laboratories
- Quantity
- 117 Kits
- Distribution
- Distribution US nationwide.
- Recall date
- March 21, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)