Recall record at a glance
| Official record | Z-2473-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Report date | Sep 6, 2023 |
| Recall initiation date | Jul 10, 2023 |
| Quantity | 19544 units |
| Location | Tarrytown, NY, United States |
Official product description
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
Why the product was 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)
Distribution information
US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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