Calibration Serum Level 3 CAL2351 recall
Calibration Serum Level 3 CAL2351
Why was Calibration Serum Level 3 CAL2351 recalled?
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
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: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE
- Product
- Calibration Serum Level 3 CAL2351
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 269 kits
- Distribution
- US Nationwide and Puerto Rico.
- Recall date
- January 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)