Recall Z-2241-2016
CSL Behring GmbH · initiated May 17, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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.
FDA-determined cause: Under Investigation by firm
Action taken
Siemens mailed an Urgent Medical Device Recall to all customers who received the affected lots notifying them of the following: 1) Discontinue use and discard any remaining inventory of the affected lots, and 2) Indicate their replacement product needs within 30 days.
Details
- Recall number
- Z-2241-2016
- Initiated
- May 17, 2016
- Terminated
- February 7, 2018
- Product code
- LPS – Urinary Homocystine (Nonquantitative) Test System
- Quantity
- 898 units
- Distribution
- 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
- Recalling firm
- CSL Behring GmbH, Marburg