Device product
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Z-2031-2012
Product summary
- Event
- Event 61769
- Status
- Terminated
- Classification
- Class II
- Quantity
- 539 kits
- Official record key
device-enforcement:Z-2031-2012
Official wording
Reason: Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.
Code information: Lot 1348873, Exp April 30, 2013
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.