device · product 1 of 1
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.
- Recall number
- Z-2241-2016
- Initiated
- May 17, 2016
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- CSL Behring GmbH
- Quantity
- 898 units
App-derived interpretation
Unknown
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.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
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.
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
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