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Recall Observatory FDA recall evidence

Device product

BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

Z-2047-2020

April 14, 2020

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 85508
Status
Terminated
Classification
Class II
Quantity
236 bottles
Official record key
device-enforcement:Z-2047-2020

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: 317740 06/30/21; 9296637 05/31/21. Expanded 5/12/20 Lot numbers:: 9296631 05/31/21; 0027824 08/31/21.

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

    reason.no_named_rule · v1.0.0

    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