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3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Model MB02-3G · UDI-DI 00817169024767
9
510(k) clearances
6
Adverse events
5
Recalls
27
Facilities
Description
Matrix Bands .002 144/Pk #3
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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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.