FDAClass IIMay 27, 2020

BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain recall

BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and…

Why was BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and…
Recalling firm
Becton Dickinson & Co.
Quantity
236 bottles
Distribution
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.
Recall date
May 27, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls