Recall Z-2046-2020 ยท JTS Stains, Microbiologic
Becton Dickinson & Co.
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
| Date | Apr 14, 2020 |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | BD issued Urgent Medical Device Notification to Customers/Distributors on 4/14/20 via FedEX stating reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog and lot numbers listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form. Even if you do not have any o |
| Quantity | 10,568 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.