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Brand name
LIFE TECHNOLOGIES CORPORATION · Model A40400 · UDI-DI 10859952006014
10
510(k) clearances
78
Adverse events
7
Recalls
51
Facilities
Description
Di Description
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.