Reported May 15, 2013 · Terminated

Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed…

Siemens Healthcare Diagnostics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics, Inc. · 2040 Enterprise Blvd · West Sacramento, CA · 95691-3427

Is this the product you have?

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.

Lot codes and dates: All lots within expirationLot
numbers
2013-02-24
2013-03-05
2013-03-06
2013-04-03
2013-04-04
2013-04-19
2013-05-01
2013-05-10
2013-05-18
2013-05-21
2013-06-07
2013-06-18
2013-06-25
2013-07-27
2013-08-10
2013-08-23
2013-09-11
2013-09-14
2013-09-28
2013-10-02
2013-11-01
2013-11-02
2013-11-15
2013-11-29
2013-12-07
2013-12-12
2013-12-17
2014-01-04
2014-01-09
2014-01-15
2014-02-01
2014-02-13
Amount recalled: 21,608 boxes = 432,160 panels

Where it was sold

Nationwide
PR

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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By hazard

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192 in total.

Where it was distributed

Puerto Rico recalls

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