FDA Device recall Z-2741-2015
Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine)
- FDA Device
- Class II
- terminated
- Published 2015-09-16
On 2015-09-16 the FDA classified a Class II recall of Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine) by Siemens Healthcare Diagnostics, citing siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2741-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-15 |
| Published | 2015-09-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.
Reason
Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively.
Identifiers
| code_info | Dimension CREA Lot Numbers: DB5195 FA5211 EA5233 DA5258 FA5275 BA5293 EA5315 EA5316 GA5342 FA5351 FA5352…Dimension CREA Lot Numbers: DB5195 FA5211 EA5233 DA5258 FA5275 BA5293 EA5315 EA5316 GA5342 FA5351 FA5352 FA6006 BA6026 BA6027 EB6047 GB6076 GA6097 BA6111 BA6112 FB6139 with expiration dates: 2015-07-14 2015-07-30 2015-08-21 2015-09-15 2015-10-02 2015-10-20 2015-11-11 2015-11-12 2015-12-08 2015-12-17 2015-12-18 2016-01-06 2016-01-26 2016-01-27 2016-02-16 2016-03-16 2016-04-06 2016-04-20 2016-04-21 2016-05-20 Dimension Vista CREA Lot Numbers: 14177BB 14212BD 14234BH 14261BC 14280BA 14301BB 14321AC 14346AC 15012AA 15042BA 15054AB 15076BA 15091BA 15125BB 15125BA 15141AA with expiration dates: 2015-06-26 2015-07-31 2015-08-22 2015-09-18 2015-10-07 2015-10-28 2015-11-17 2015-12-12 2016-01-12 2016-02-11 2016-02-23 2016-03-16 2016-03-31 2016-05-04 2016-05-04 2016-05-22 |
|---|
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-2741-2015%22
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