BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffe

FDA device recall Z-1392-2012 · posted 2012-04-10 · Terminated

Recall details

Recalling firm

Biocare Medical Llc

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.

Action taken

"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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NJT

Quantity affected

74 kits

Distribution

Worldwide 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,

Date initiated

2012-03-13

Date posted

2012-04-10

Date terminated

2012-09-20

Location

Concord, CA