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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 O162 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O113 serum, 3 mL — Ssi Diagnostica A/S E. coli O147 serum, 1 mL — Ssi Diagnostica A/S E. coli OK O114 serum, 3 mL — Ssi Diagnostica A/S E. coli O123 serum, 1 mL — Ssi Diagnostica A/S E. coli O108 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O183 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O22 serum, 1 mL — Ssi Diagnostica A/S E. coli O51 serum, 1 mL — Ssi Diagnostica A/S E. coli H34 serum, 5 mL — Ssi Diagnostica A/S E. coli O99 serum, 1 mL — Ssi Diagnostica A/S E. coli O186 serum, 1 mL — Ssi Diagnostica A/S E. coli O157 serum, 3 mL — Ssi Diagnostica A/S E. coli O25 serum, 1 mL — Ssi Diagnostica A/S E. coli O41 serum, 1 mL — Ssi Diagnostica A/S E. coli O112ac serum, 1 mL — Ssi Diagnostica A/S E. coli O103 serum, 1 mL — Ssi Diagnostica A/S E. coli O74 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O56 serum, 1 mL — Ssi Diagnostica A/S E. coli O134 serum, 1 mL — Ssi Diagnostica A/S E. coli O180 serum, 1 mL — Ssi Diagnostica A/S E. coli O81 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O42 serum high titer, 1 mL — Ssi Diagnostica A/S E. coli O172 serum, 1 mL — Ssi Diagnostica A/S

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.