Device Recall Vysis Paraffin Pretreatment Reagent Kit II

  • Model / Serial
    list 07J02-002, part number 32-801210, lot numbers 420563, 420008 and 418294
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Argentina, Austria, Belarus, Belgium, Canada, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Kuwait, Lebanon, Lithuania, the Netherlands, Panama, Poland, Singapore, Slovenia, South Africa, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Vietnam.
  • Product Description
    Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I (Pepsin, lyophilized, activity 1:3000 to 1:3500); Abbott Molecular Inc; list 07J02-002, part number 32-801210. invitro diagnostic.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    list 07J02-003, part number 32-801230, lot numbers 420063 and 418669
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Argentina, Austria, Belarus, Belgium, Canada, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Kuwait, Lebanon, Lithuania, the Netherlands, Panama, Poland, Singapore, Slovenia, South Africa, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Vietnam.
  • Product Description
    Paraffin Pretreatment Reagent Kit III; each kit contains the following: || 5 x 50 mL Pretreatment Solution (1N sodium thiocyanate - NaSCN), || 5 x 62.5 mL Protease Buffer III (50 mM Tris base, pH 8.0 5 mM Calcium Chloride - 2H2O 0.1% SDS), || 5 x 9.0 mg Protease III (Proteinase K, 35 <= x <= 38 Units/mg) || 2 x 200 mL Protease Stop Solution (0.01N hydrochloric acid - HCl); || Abbott Molecular Inc; list 07J02-003, part number 32-801230. invitro diagnostic.
  • Manufacturer