Recall Z-1272-2013— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1272-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-06

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-03-06, terminated 2013-10-28. It names one FDA 510(k) clearance: K091949. Product: Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.. Reason: Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Terminated: 2013-10-28
Firm location: West Sacramento, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K091949 — MICROSCAN MICROSTREP PLUS, MODEL B1027-201Siemens Healthcare Diagnostics·cleared 2010-01-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.

Reason for recall

Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.

Data sourced from openFDA. This site is unofficial and independent of the FDA.