Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 19, 2025
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
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 err…
Becton Dickinson & Co. recalled BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; - a moderate-severity action.
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; was recalled by Becton Dickinson & Co. in November 19, 2025. Reason: The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly …. Check the official notice for the remedy. Verify recall #Z-0484-2026 with the FDA Devices before acting.
The recall
Becton Dickinson & Co. issued this moderate-severity FDA Devices recall-The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly ….
- Moderate
- severity level
- 30K units
- affected scope
- Class II
- classification
- November 19, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0484-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0484-2026) was formally reported on November 19, 2025, with the manufacturer initiating the action on October 23, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Becton Dickinson & Co. is listed as the recalling firm, operating out of Sparks, MD. Federal records list the affected scope as 29,760 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
29,760 units
Related Recalls
6
3 from same agency
Product description
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0484-2026 |
| Date reported | November 19, 2025 |
| Date initiated | October 23, 2025 |
| Recalling firm | Becton Dickinson & Co. |
| Firm location | Sparks, MD |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0484-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;. Recalled by Becton Dickinson & Co.. Units affected: 29,760 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2025. Severity: Moderate. Recall number: Z-0484-2026.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0484-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 19, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.