Exact FDA event identifier

Event 72176

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 10, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Beckman Coulter Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

Z-0108-2016

Recall number: Z-0108-2016
Initiated: September 10, 2015
Classification: Class II
Status: Terminated
Recalling firm: Beckman Coulter Inc.
Quantity: 5138 units total (4,360 units in US)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.

Code information

2016-01-27 2016-02-27 2016-03-26 2016-04-02 2016-04-14 2016-05-01 2016-05-15 2016-06-12

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Bahamas, Belgium, Canada, Ecuador, Germany, Italy, Republic of Korea, Mexico, Peru, Poland, Romania, Saudi Arabia, South Africa, Thailand, United Sates (including Puerto Rico), and Uruguay.

device · product 2 of 2

MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

Z-0109-2016

Recall number: Z-0109-2016
Initiated: September 10, 2015
Classification: Class II
Status: Terminated
Recalling firm: Beckman Coulter Inc.
Quantity: 438 units total (433 units in US)