Z-1415-2023 Class II Ongoing
FDA device recall Z-1415-2023 was initiated by Becton Dickinson & Co. on March 22, 2023 and is designated Class II. Reason for recall: Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occurred. This could pos… The recall status is ongoing. Affected quantity: 7 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- March 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 instruments
Product Description
BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213
Reason for Recall
Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occurred. This could possibly lead to a delayed diagnosis and/or treatment or need for specimen recollection streaking plated media, and inoculating tubes and slides. In Semi-Automated (SA) mode, plates are automatically selected, barcoded, streaked in a pre-configured pattern while the user manually inoculates plates, tubes, and slides. An optional biosafety cabinet on the SA module provides personnel, product, and environmental protection. The InoqulA+" solution is indicated for use in the clinical laboratory.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of IL, NY and the countries of Netherlands, Saudi Arabia.
Code Information
UDI: 038290LSUVLPKFPV Serial Numbers: INO-000156, INO-000249, INO-000248, INO-000252, INO-000254, 20130276, 19033ST002