Atellica CH LDL Cholesterol- In vitro diagnostic use in recall
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin…
Why was Atellica CH LDL Cholesterol- In vitro diagnostic use in recalled?
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿ CH HDL Cholesterol (HDLC)
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?
Unique Device Identification (UDI): 00630414611037 All Lot Numbers
- Product
- Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 6733 units
- Distribution
- US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam
- Recall date
- September 6, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)