CLASS II ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report
BD Kiestra" Isolate Suspension Cuvette Array recalled
Becton Dickinson is recalling BD Kiestra" Isolate Suspension Cuvette Array, distributed nationwide in the US. The recall was initiated on 23 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0484-2026
- FDA event ID
- 97817
- Recalling firm
- Becton Dickinson, Sparks, MD
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Oct 2025
- FDA classified
- 7 Nov 2025
- Reported
- 19 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Oct 2025 | Recall initiated by company | |
| 7 Nov 2025 | Classified by FDA | +15 days |
| 19 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Where it was distributed
Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.
Nationwide ColoradoConnecticutKentuckyNew JerseyTennesseeTexasUtah
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666;
Where was it sold?
Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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