FDA Device recall Z-2283-2020
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative de…
- FDA Device
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative de… by Siemens Healthcare Diagnostics, citing the presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2283-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-04 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
Reason
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Identifiers
| code_info | Lot #s 100051, 100025, 100002, 190294, 190256, 190200, 190171, 190135, 190126 ***Added 9/9/20*** 100087…Lot #s 100051, 100025, 100002, 190294, 190256, 190200, 190171, 190135, 190126 ***Added 9/9/20*** 100087 ***Added 11/2/20*** 100109 100136 100167 ***Added 3/11/21*** 110032 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2283-2020%22
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