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Dimension® Flex® reagent cartridge ALPI

Siemens Healthcare Diagnostics Inc. · Model 10642445 · UDI-DI 00842768039010

CJO
1
510(k) clearances
1
Adverse events
1
Recalls
3
Facilities

Description

Alkaline Phosphatase Flex® reagent cartridge, 360 tests

Recalls

DateFirmReason
2020-08-25Siemens Healthcare Diagnostics, Inc.Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration

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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.