LIEClass II

Reagent/device, Inoculum Calibration

Microbiology · 21 CFR 866.1640

MDR events1All time

Recalls2All time

Registered firms6Currently listed

510(k) clearances7All time

Recent MDR events

1 adverse event reports on file

INFORMMay 27, 2005
InjuryRoche Diagnostics Corp.609402

Event type breakdown

Injury1

Most-reported manufacturers

Roche Diagnostics Corp.1

Recalls

2 recall events for this product code

Beckman Coulter Inc.
TerminatedApr 6, 2020
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to
Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results.
Z-1674-2020 · View FDA record ↗
Dade Behring, Inc.
TerminatedDec 5, 2006
Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;
Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.
Z-0247-2007 · View FDA record ↗

Registered firms

6 firms currently registered for this product code

510(k) clearances

7 clearances for this product code