Recall Z-2048-2020
Becton Dickinson & Co. · initiated April 14, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
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
FDA-determined cause: Under Investigation by firm
Action taken
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 of the affected lots in your inventory, please complete the Customer Recall Response Form indicating you have zero (0) quantity and return as indicated above. Distributors requested to provide customer list to BD. BD will provide a product replacement for all discarded inventory. BD Customer/Technical Support 800-638-8663, Monday Friday between 7:00am and 7:00pm (EST) in the United States. For customers outside the United States, contact your local BDrepresentative or distributor. On 5/12/20 firm expanded the recall to an additional six (6) lots of product.
Details
- Recall number
- Z-2048-2020
- Initiated
- April 14, 2020
- Terminated
- February 10, 2022
- Product code
- JTS – Stains, Microbiologic
- Quantity
- 1469 kits
- 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.
- Recalling firm
- Becton Dickinson & Co., Sparks, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2046-2020 Class II | BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms…May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci… | 04/14/2020Terminated |
| Z-2047-2020 Class II | BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms…May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci… | 04/14/2020Terminated |