Recall Z-0484-2026 ยท LIB Device, General Purpose, Microbiology, Diagnostic
Becton Dickinson & Co.
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
| Date | Nov 7, 2025 (initiated Oct 23, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On October 23, 2025 URGENT: Medical Device Correction letters were sent to customers. Actions for Clinical Users: 1. Immediately inspect your inventory for the specific catalog and lot numbers listed to determine if the lot in your possession is impacted and immediately discard any remaining inventory of the affected product. 2. *Note: Lot LM245666 has undergone rework and will be used as replacement material for affected product. Reworked inventory from this lot can be identified using the indicators described in ATTACHMENT 1- How to Identify Affected vs Reworked Product. Action to be taken b |
| Quantity | 29,760 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.