FDA Device recall Z-1457-2015
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894
- FDA Device
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894 by Siemens Healthcare Diagnostics, citing siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier result….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1457-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-23 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Reason
Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier results when running with Triglycerides, Triglycerides_2, Triglycerides_c, Cholesterol concentrated, and DLDL reagents.
Identifiers
| code_info | Catalog Number: B01-4840-01; Material Number (SMN)10311896, Lot Numbers: 318706, 332463, expiration dates 2015-06-30, 2015-08-31 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1457-2015%22
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