BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 23, 2025 |
| Reported | November 19, 2025 |
| Recalling firm | Becton Dickinson & Co. |
| Country / region | United States MD |
Hazard
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.
Affected products
- BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Related recalls
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER