Z-1522-2015Class II

MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34...

Name: Z-1522-2015 MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34...
Creator: Beckman Coulter, Inc.
Published: 2014-05-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-05-14 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining... on 2014-05-14. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28". 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-1522-2015
Classification: Class II
Status: Terminated
Initiated: 2014-05-14
Posted: 2015-04-26
Terminated: 2015-04-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of colonies, grown 34 on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Siemens sent an Urgent Medical Device Recall letter dated May 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The risk to health is explained and users are asked to discontinue use and discard any of the recalled lot still in inventory. No other lot numbers of the NBPC 34 panels are affected and may still be used. The Field Correction Effectiveness Check form should have been completed and returned to Siemens. PLEASE FAX THIS COMPLETED FORM TO 302-631-8467. Contact Siemens Customer Care Center or local Siemens Tech support. For further questions please call (916) 374-3031
Quantity in commerce: 681 boxes
Distribution: Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Canada, Kuwait, South Africa and Turkey.
Product codes and lots: Catalog Number B1017-404, lot # 2014-05-28, Expiry 2014-05-28.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1522-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1522-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-26

Product code JWY

K862140Class IIMicrodilution PanelsAmerican Micro Scan / cleared 1986-07-16

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)