Recall Z-0127-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0127-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-14

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2014-08-14, terminated 2015-08-10. It names one FDA 510(k) clearance: K102045. Product: Dimension Vista¿ HbA1c. Reason: In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-08-14
Terminated: 2015-08-10
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K102045 — DIMENSION VISA HBA1C, MODEL K3105ASiemens Heatlhcare Diagnostics, Inc.·cleared 2011-02-14

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¿ HbA1c

Reason for recall

In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t

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