Z-0562-2016Class II

MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed...

Name: Z-0562-2016 MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed...
Creator: Beckman Coulter Inc.
Published: 2015-12-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-12-01 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent... on 2015-12-01. FDA classified it as Class II and gives the reason as "Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0562-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-01
Posted: 2015-12-30
Terminated: 2016-07-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Product code: LTT Panels, Test, Susceptibility, Antimicrobial
Reason for recall: Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to discontinue use and discard any remaining inventory of lots listed; return the attached form for product replacement; retain your inventory of the other lot numbers of the panel types, as they are not impacted by this issue; discuss content of the letter with your laboratory director/staff, retain the notification as part of your laboratory QS documentation; if you have forwarded any of the affected products to another laboratory provide them a copy of the letter, and complete and return the enclosed Response Form within 10 days via mail to: Beckman Coulter, Inc., 1584 Enterprise Blvd., West Sacramento, CA 95691, Attn: Quality Systems & Compliance or Fax: 916-374-2119 or email: [email protected]. Customers with questions are instructed to contact their Customer Support Representative at http://www.beckmancoulter.com or by phone at (800) 677-7226 in US and Canada.
Quantity in commerce: 715 units total (616 units in US)
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
Product codes and lots: 2016-05-06 Part No. B1017-206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0562-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0558-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-30
Z-0559-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-30
Z-0560-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-30
Z-0561-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-30
Z-0562-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-30

Product code LTT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)