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U.S. Department of Health and Human Services

Class 2 Device Recall Vina Green(tm) Chromogen Kit

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 Class 2 Device Recall Vina Green(tm) Chromogen Kitsee related information
Date Initiated by FirmMarch 13, 2012
Date PostedApril 10, 2012
Recall Status1 Terminated 3 on September 20, 2012
Recall NumberZ-1392-2012
Recall Event ID 61395
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
ProductBioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells.
Code Information Catalog number VG807H, lot 060211 and 101211; expiration 5/2013; Catalog number VG807S, lot 053111, 060211; both with expiration of 5/2013; lot 101211, Expiration 8/2013.
FEI Number 3004140393
Recalling Firm/
Manufacturer		 Biocare Medical Llc
4040 Pike Ln
Concord CA 94520
For Additional Information ContactScott Huntsman
925-603-8002
Manufacturer Reason
for Recall		Reports of sporadic failure of specific lots of Vina Green Chromogen Kit, either through crystal formation that obscures positive staining, color not right, or a complete fading of staining by the chromogen.
FDA Determined
Cause 2		Nonconforming Material/Component
Action"Medical Device Recall Notification" letters were sent on March 13, 2012 to all direct account. Letters informed customers of the reason for recall and the specific lots and catalog numbers involved, along with the reason for recall, how to identify the recalled product, and the actions to be taken. Customers were to immediately discontinue use of the affected product lot(s). They should dispose of the product according to national, state, and local laws and regulations. The enclosed Return Response Form should be completed and returned. Customers will be credited upon receipt of the Response Form.
Quantity in Commerce74 kits
DistributionWorldwide Distribution -- USA, including the states of WI, KY, CA, GA, IN, MA, IL, MD, NC, LA. AZ, TX, NC, NJ, MO, NY, PA, OH, DC, MI, WA, and CO, and the countries of Canada, Sweden, Germany, Italy, and Switzerland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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