Device product
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Z-0484-2026
Product summary
- Event
- Event 97817
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29,760 units
- Official record key
device-enforcement:Z-0484-2026
Official wording
Reason: The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
Code information: Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666;
Distribution pattern: Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.
Derived failure modes
-
Unknown
The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.