Recall Z-1151-2013— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-02-21, terminated 2014-01-07. It names 2 FDA 510(k) clearances: K112142, K093441. Product: Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.. Reason: Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-21
- Terminated
- 2014-01-07
- Firm location
- Newark, DE, United States
510(k) clearances named in this recall
2 on FDA's record- K112142 — DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
- K093441 — DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
Reason for recall
Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.
Data sourced from openFDA. This site is unofficial and independent of the FDA.