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62 catalysts · 29 approval · 16 device 510k · 10 grant · 5 device pma · 2 device recall
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62 catalysts · 29 approval · 16 device 510k · 10 grant · 5 device pma · 2 device recall
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; — Reason: A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes. — Status: Ongoing
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 — Reason: Surgical light assembly may not adequate support the weight of the ceiling cover. — Status: Ongoing
GM grant. $84,940. PI: June-Yung Kim
AI grant. $862,748. PI: Ype Peter De Jong
AI grant. $437,250. PI: Emrullah Korkmaz
AI grant. $417,295. PI: Kevin S. McIver
AI grant. $243,600. PI: Ekaterina Heldwein
AI grant. $416,622. PI: Alban Longchamp
AT grant. $29,965. PI: Marcy J Balunas
NS grant. $250,000. PI: Thomas G Bifano
AI grant. $632,994. PI: Jeanne Ann Hardy
DC grant. $687,094. PI: Ulrich Mueller