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Dimension® Flex® reagent cartridge LI

Siemens Healthcare Diagnostics Inc. · Model 10444939 · UDI-DI 00842768005367

JIH
1
510(k) clearances
20
Adverse events
2
Recalls
14
Facilities

Description

Lithium Flex® reagent cartridge, 80 tests

Recalls

DateFirmReason
2017-02-01Ortho-Clinical DiagnosticsIntermittent imprecision in results generated using two specific lots of VITROS Li Slides.
2013-06-12Ortho-Clinical DiagnosticsOrtho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

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Data 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.