Recall Z-2438-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2438-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-21

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-03-21, terminated 2020-06-12. It names one FDA 510(k) clearance: K151529. Product: Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586. Reason: The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-21
Terminated: 2020-06-12
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K151529 — Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone CalibratorSiemens Healthcare Diagnostics, Inc.·cleared 2016-02-11

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

Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586

Reason for recall

The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.

Data sourced from openFDA. This site is unofficial and independent of the FDA.