Device product
BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Z-2048-2020
Product summary
- Event
- Event 85508
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1469 kits
- Official record key
device-enforcement:Z-2048-2020
Official wording
Reason: May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain
Code information: Lot Number/ Exp Date: 0007261 06/30/21; 0007255 05/31/21; 0028309 03/30/21. Expanded 5/12/20-Lot Numbers/Exp. Date: 0041114 07/31/21; 0014322 06/30/21
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, Taiwan, Hong Kong, Chile, EMEA, Thailand, China, Japan, Australia, New Zealand, Korea, Costa Rica, Mexico, Canada, and Singapore.
Derived failure modes
-
Unknown
May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain