Z-0109-2016Class II

MICroSTREP plus 2 Panel, Part No. B1027-202

Name: Z-0109-2016 MICroSTREP plus 2 Panel, Part No. B1027-202
Creator: Beckman Coulter Inc.
Published: 2015-09-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-09-10 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative... on 2015-09-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0109-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-10
Posted: 2015-10-07
Terminated: 2016-01-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: LTT Panels, Test, Susceptibility, Antimicrobial
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Beckman Coulter Inc. sent an Urgent Medical Device Recall letter dated Setember 10, 2015 to all customers who purchased the MICroSTREP plus 1 and MICroSTREP plus 2. The letter identified the affected products, problem and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions regarding the notice, are instructed to contact their Customer Support Representative:website: http://www.beckmancoulter.com or by phone: 1-800-677-7226 in the United States and Canada.
Quantity in commerce: 438 units total (433 units in US)
Distribution: 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.
Product codes and lots: 2016-01-30 2016-03-23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0109-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0108-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-07
Z-0109-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-07

Product code LTT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)