Recall Z-2241-2016— CSL Behring GmbH

Name: FDA recall Z-2241-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-17

Class II · Terminated

Class II FDA medical device recall by CSL Behring GmbH, initiated 2016-05-17, terminated 2018-02-07. It names one FDA 510(k) clearance: K063206. Product: Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.. Reason: Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed..

Recalling firm: CSL Behring GmbH
Classification: Class II
Status: Terminated
Initiated: 2016-05-17
Terminated: 2018-02-07
Firm location: Marburg, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K063206 — DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.·cleared 2006-12-28

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¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.

Reason for recall

Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.

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