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Swelab Lumi-L1 Lyse
Boule Medical AB · Model Swelab Lumi-L1 Lyse 200mL · UDI-DI 07350040796436
10
510(k) clearances
78
Adverse events
7
Recalls
51
Facilities
Description
The reagents are accessories intended to be used in combination with the Swelab Lumi analyzer. The lyse reagents lyses the red blood cells and maintain the morphology of white blood cells enabling sizing and counting of white blood cells and measurement of hemoglobin release from lysed red blood cells
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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Get your free API keyRead the docsData 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.