FDA Device recall Z-1790-2020
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum
- FDA Device
- Class II
- terminated
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum by Csl Behring, citing negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1790-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-02 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Csl Behring |
| Distribution | IN, KS, MO, OH, VA |
Product
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
Reason
Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring
Identifiers
| code_info | US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11 |
|---|
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-1790-2020%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.