Z-1272-2013Class II

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

Name: Z-1272-2013 Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-03-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-03-06 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial... on 2013-03-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1272-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Posted: 2013-05-08
Terminated: 2013-10-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: LTT Panels, Test, Susceptibility, Antimicrobial
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.
FDA root cause: Under Investigation by firm
Action: Siemens Healthcare sent a Urgent Field Safety Notification letter dated March 6, 2013, to all affected customers of MicroScan MICroSTREP plus type 1, who process panels in a Walk Away System. The letter identified the product the problem and the action needed to be taken by the customer. As stated in our product Instructions for Use, test results should be interpreted in conjunction with the patients medical history, clinical presentation and other findings. We recommend discussing the content of this letter with your laboratory director regarding the need to review previous test results, conduct patient follow-up, and/or repeat testing for testing conducted in the last twelve months. Confirmation of receipt of this letter is required. Attached you will find a form indicating you have received and understood the information. We would greatly appreciate your assistance in notifying us that you have received the information by taking a moment to complete and return the form below. If you require further information or assistance, please contact your local Siemens Healthcare Diagnostics Representative. Please forward this notification to anyone to whom you may have distributed this product. We apologize for the inconvenience that this situation has caused. For further questions please call 1-800-677-7226 Option 1 (USA/Canada) Thank you for your patience and continued support.
Quantity in commerce: 21,608 boxes = 432,160 panels
Distribution: US Nationwide Distribution including Puerto Rico.
Product codes and lots: All lots within expiration: Lot 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1272-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1272-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-08

Product code LTT

K091949Class IIMicroscan Microstrep Plus, Model B1027-201Siemens Healthcare Diagnostics / cleared 2010-01-26

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)