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BD PhoenixSpec™ Calibrator 0.25 McFarland

BECTON, DICKINSON AND COMPANY · Model 441355 · UDI-DI 00382904413552

JQX Prescription
10
510(k) clearances
260
Adverse events
4
Recalls
13
Facilities

Description

BD PhoenixSpec™ Calibrator 0.25 McFarland

Recalls

DateFirmReason
2017-06-01Becton Dickinson & Co.Potential unexpected movement of robot arm
2010-05-21Beckman Coulter Inc.Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control and patient samples using the lots
2006-01-17Becton Dickinson & Co.A operator's manual for a diagnostic test kit is incorrect and may cause inaccurate results for bacterial identification and antibiotic susceptibility in patient samples.
2005-12-01Becton Dickinson & Co.A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity.

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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.