Liquid Assayed Chemistry Control Premium Plus Level 3 recall
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Why was Liquid Assayed Chemistry Control Premium Plus Level 3 recalled?
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
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?
UDI-DI: 05055273208986; Lot Number: 1308UE
- Product
- Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 66 kits
- Distribution
- US States: GA, OH, OR, PA, TX, VA
- Recall date
- September 27, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)