Food, drugs, devices › Sysmex America Inc
Device recall: Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the co
FDA enforcement event 74654 is a device recall by Sysmex America Inc of Lincolnshire, IL, initiated 1 Jul 2016 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 10 Feb 2017. Initiation: voluntary: firm initiated. Sysmex America Inc has 12 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Sysmex America Inc, Lincolnshire, IL.
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"…"
Distribution
"Worldwide Distribution - US (Nationwide, Washington DC) Canada; Cuba; Chile; and Dominican Republic."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2770-2016 | 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 | 3868 units | Class II | Terminated | 21 Sep 2016 |
Context
Other enforcement events for Sysmex America Inc
All 12 events for Sysmex America Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (Nationwide, Washington DC) Canada; Cuba; Chile; and Dominican Republic."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Feb 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.