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Lysercell WNR

SYSMEX CORPORATION · Model AN577063 · UDI-DI 04987562422982

GGK Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Lysercell WNR is a reagent product to be combined and used with Fluorocell WNR. By hemolyzing red blood cells with Lysercell WNR and by differentiating white blood cells (non-basophil), basophils, and nucleated red blood cells with Lysercell WNR and Fluorocell WNR, the white blood cell count, basophil count, basophil percentage, nucleated red blood cell count, and nucleated red blood cell percentage are analyzed. This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex.

Recalls

Date	Firm	Reason
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2011-07-11	Beckman Coulter Inc.	The recall was initiated because Beckman Coulter identified unexpected high particle counts in the lots of DxH Cell Lyse listed. These lots may generate high background counts; cou
2011-04-11	Sysmex America, Inc.	The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased fals
2011-04-08	Beckman Coulter Inc.	The recall was initiated because Beckman Coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the Coulter A T 5 diff PN 8547171
2010-12-28	Beckman Coulter Inc.	The recall was initiated by Beckman Coulter because the COULTER LYSE III diff Lytic Reagent Lot number 101554F was released for distribution to customers between November 17 and De
2009-06-23	Sysmex America, Inc.	The affected lots of Stromatolyser-IM lysing reagent was found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false
2007-12-19	Abbott Laboratories	Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

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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.