Z-2241-2016 Class II Terminated
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 February 7, 2018). Affected quantity: 898 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2016
- Initiation Date
- May 17, 2016
- Termination Date
- February 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