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Dimension® Flex® reagent cartridge NAPA

Siemens Healthcare Diagnostics Inc. · Model 10444936 · UDI-DI 00842768005299

LAN
1
510(k) clearances
0
Adverse events
1
Recalls
7
Facilities

Description

N-Acetylprocainamide Flex® reagent cartridge, 80 tests

Recalls

DateFirmReason
2010-02-05Roche Diagnostics Operations, Inc.The N-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. The correct expiration date for the lot is 1/31/2011.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.