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SPOTCHECK

ASTORIA-PACIFIC, INC. · Model 81-1100-05K · UDI-DI 00725609000601

JNB Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities

Description

Phenylalanine Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Phenylalanine Levels in Neonates

Recalls

DateFirmReason
2012-11-26PerkinelmerTruncated V-Bottomed Microplate Wells used in assays contain defective wells.
2010-01-26Bio-Rad Laboratories IncPressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.

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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.