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Antisera, All Types, Escherichia Coli

FDA product code GNA · Class 1 · Microbiology

500

Registered devices

0

Adverse events

1

Recalls

12

510(k) clearances

Devices with this code

E. coli O8 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O71 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O126 serum, 1 mL — Ssi Diagnostica A/S Prolex E. coli O157 Latex Test Reagent Kit (100 tests) — PRO-LAB, INCORPORATED E. coli O58 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O139 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli H23 serum, 5 mL — Ssi Diagnostica A/S E. coli O98 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O141 serum, 1 mL — Ssi Diagnostica A/S E. coli OK O158 serum, 3 mL — Ssi Diagnostica A/S E. coli O142 serum high titer, 1 mL — Ssi Diagnostica A/S BD Difco™ Escherichia coli H Antiserum H7 — BECTON, DICKINSON AND COMPANY E. coli O146 serum, 3 mL — Ssi Diagnostica A/S E. coli H29 serum, 5 mL — Ssi Diagnostica A/S E. coli H11 serum, 5 mL — Ssi Diagnostica A/S Prolex E. coli O121 Latex Reagent — PRO-LAB, INCORPORATED E. coli O150 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O113 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O61 serum, 1 mL — Ssi Diagnostica A/S E. coli O154 serum, 1 mL — Ssi Diagnostica A/S E. coli H19 serum, 5 mL — Ssi Diagnostica A/S Prolex E. coli O111 Latex Reagent — PRO-LAB, INCORPORATED E. coli O155 serum, 1 mL — Ssi Diagnostica A/S Prolex E. coli Non-O157 Identification Kit — PRO-LAB, INCORPORATED

Recent recalls

Date	Firm	Reason
2016-11-08	Meridian Bioscience Inc	Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.