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maandag 3 december 2018

IGJ waarschuwingen: Sartorius Stedim Biotech, FSCA-2018-11-12, Minisart® NML

Sartorius Stedim Biotech, FSCA-2018-11-12, Minisart® NML
we identified some filters with wrong assembled membranes, i.e. l.2 um instead of 0.2 um pore síze.
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MicroPort Orthopedics, MP_FSCA181115, PROFEMUR® TL Classic Stem size 7 Straight Short
During MicroPort's investigation, the affected lots of the PROFEMUR® TL Classic Stem were confirmed to have the plasma coating transition line sprayed 2mm higher than specification on the medial-proximal portion of the stem.
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Fast Track Diagnostics FSN_20181109 - FastFinderFTlyo2+.1, FTlyo2P.3, FTlyo48.1, FTlyo56.1
FTD has become aware that the information contained in the user manuals listed above contains incorrect information regarding the use of FastFinder.
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Randox Laboratories REC340 - Evidence Investigator SW
Evidence Investigator software version 2.1.1 is now available. This includes a number of new features as detailed in the Software Release Notes in the accompanying email. A failure to detect reference and correction DTRs causes no test result to be reported.
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Biohit Oyj, 165-18, Lactose intolerance quick test
We have recently noticed some anomalies with the kit lots mentioned above.
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