Immunoassay Premium Plus Controls recall
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed…
Why was Immunoassay Premium Plus Controls recalled?
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
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?
Lot codes: 1714EC 430312 432364
- Product
- Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed…
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 12
- Distribution
- The products were distributed to the following US states: WV and Puerto Rico.
- Recall date
- April 17, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)