Home / Recalls / CSL Behring GmbH / Z-2241-2016

Z-2241-2016 Class II Terminated

Recalled by CSL Behring GmbH — Marburg, N/A

FDA device recall Z-2241-2016 was initiated by CSL Behring GmbH on May 17, 2016 and is designated Class II. 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. The recall status is terminated (terminated Feb 7, 2018). Affected quantity: 898 units.

Recall details

Product Type: Devices
Report Date: Jul 27, 2016
Initiation Date: May 17, 2016
Termination Date: Feb 7, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 898 units

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.

Distribution pattern

Distributed to: AL, AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV

Code information

Lot Number 15243MA Mfg Date: 08/31/2015 Exp Date: 05/31/2016 Lot Number 15243MB Mfg Datge: 08/31/2015 Exp Date: 05/31/2016

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2241-2016
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.