Atellica CH Gamma-Glutamyl Transferase-IIn vitro recall
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and…
Why was Atellica CH Gamma-Glutamyl Transferase-IIn vitro 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): 00630414596440 All Lot Numbers
- Product
- Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 19544 units
- Distribution
- US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam
- Recall date
- September 6, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)