FDA Devices recall · Reported September 21, 2016
Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IP…
Sysmex America Inc recalled Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a… - a moderate-severity action.
Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a… was recalled by Sysmex America Inc in September 21, 2016. Reason: There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performe…. Check the official notice for the remedy. Verify recall #Z-2770-2016 with the FDA Devices before acting.
The recall
Sysmex America Inc issued this moderate-severity FDA Devices recall-There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performe….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- September 21, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2770-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
Reason for recall
There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IPF values. The issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) value and a false low PLT-F value. In most cases, the falsely decreased PLT-F results displayed a "PLT Abn Scattergram" message with asterisks beside the results indicating the data is unreliable. In rare instances, platelet flags may be absent. The PLT-I counts are unaffected. The PLT-F is a reflex test used to confirm PLT-I results due to flagging or low values. As such, the likely impact to patient results is low. Affected results display a discrepancy between the PLT-I and PLT-F, with lower than expected PLT-F results that do not match the patient's clinical picture.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2770-2016 |
| Date reported | September 21, 2016 |
| Date initiated | July 1, 2016 |
| Recalling firm | Sysmex America Inc |
| Firm location | Lincolnshire, IL |
| Affected scope | 3868 units |
| Distribution | Worldwide Distribution - US (Nationwide, Washington DC) Canada; Cuba; Chile; and Dominican Republic. |
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-2770-2016) 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.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026