Z-2048-2020 Class II Terminated
FDA device recall Z-2048-2020 was initiated by Becton Dickinson & Co. on April 14, 2020 and is designated Class II. 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 The recall status is terminated (terminated February 10, 2022). Affected quantity: 1469 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- April 14, 2020
- Termination Date
- February 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1469 kits
Product Description
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.
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
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.
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