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Atellica IM Calibrator D

Siemens Healthcare Diagnostics Inc. · Model 10995509 · UDI-DI 00630414598369

LOKLOJ
1
510(k) clearances
162
Adverse events
1
Recalls
10
Facilities

Description

Calibrator D - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL

Recalls

DateFirmReason
2003-06-12Abbott Laboratories HPD/ADDAFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%

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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.