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STROMATOLYSER-4DS

SYSMEX CORPORATION · Model FFS-800A · UDI-DI 10664369201385

KQC Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Stain reagent for hematology analyzers

Recalls

Date	Firm	Reason
2018-07-27	Sysmex America, Inc.	The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.
2017-09-08	Sysmex America, Inc.	There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower than actual PLT-F and I
2016-07-01	Sysmex America Inc	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
2011-04-04	EMD Chemicals Inc.	Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens.
2007-07-30	EMD Chemicals Inc	Out of Spec -- The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matte

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.