FDA Device recall Z-2284-2020
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determ…
- FDA Device
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determ… 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-2284-2020 |
| 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
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - 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 FC0324, BB0262, GD0218, GC0184, FB0122 ***Updated 8/4/20*** GF1006 ***Added 9/10/20*** FB1050 ***Added 11/2/20*** EA1102 |
|---|
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-2284-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.