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Pointe Scientific, Inc. Microprotein Standard

HORIBA INSTRUMENTS INCORPORATED · Model P7582-STD · UDI-DI 00811727011923

JGP Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
9
Facilities

Description

Pointe Scientific, Inc. Microprotein Standard is intended for use as a microprotein standard for standardization or calibration of pyragallol red microprotein procedures. 1 x 15 ml.

Recalls

DateFirmReason
2016-12-08Ortho-Clinical DiagnosticsThere is a potential for variable negatively and positively biased urine protein results using VITROS UPRO 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.