Laboratory cuvette arrays recalled over barcodes the analyser cannot read
Becton Dickinson is recalling 29,760 BD Kiestra Isolate Suspension Cuvette Arrays because formatting errors in the 2D barcodes stop the analyser reading the expiration date.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the stated consequence is that the cuvettes cannot be used, not an erroneous result or reported harm.
Plain-English summary
The BD Kiestra Isolate Suspension Cuvette Array, catalog number 246100, is being recalled.
The 2D barcodes on these cuvettes contain formatting errors that prevent the analysing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
The recall covers 29,760 units carrying UDI-DI 30382902461006, from lots LM245590, LM245592, LM245593, LM245594 and LM245666. Distribution was worldwide, including in Colorado, Connecticut, Kentucky, New Jersey, Tennessee, Texas and Utah, and to Belgium among other countries. The FDA has classified the action as Class II.
The enforcement record describes an instrument error state and unusable consumables, without stating a health consequence or reported injury. Laboratories holding affected lots should follow BD's instructions.
The recalled product
- Product
- BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 29,760
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Catalog No.: 246100
- UDI-DI: 30382902461006
- Lot Number: LM245590
- LM245592
- LM245593
- LM245594
- LM245666
Distribution
Related recalls
Same manufacturer · Becton Dickinson & Co.
See all →- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- HighAutomated microbiology systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
- HighBlood culture systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
- HighVeritor Connect software recalled after service credentials accessed by unauthorized actor
FDA (Devices) · 2025-10-29
Same hazard · barcode error
See all →- HighCell morphology analyzers recalled over barcodes read from the previous slide
FDA (Devices) · 2025-11-26
- HighFood allergen panels recalled over barcodes causing wrong tube scanning order
FDA (Devices) · 2025-11-19
- HighAllergy IgE universal kits recalled over barcodes misordering tubes in wedges
FDA (Devices) · 2025-11-19
- HighOak mix allergen tests recalled over barcode orientation misreading tube positions
FDA (Devices) · 2025-11-19
- HighSynthroid Levothyroxine Tablets Recalled for Incorrect Barcode Labeling
FDA (Drugs) · 2023-11-15