Z-1255-2015Class II

RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are...

Name: Z-1255-2015 RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2014-12-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-12-30 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics Inc began a recall of RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare... on 2014-12-30. FDA classified it as Class II and gives the reason as "Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1255-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-30
Posted: 2015-03-06
Terminated: 2017-08-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb.
Product code: MQM Bilirubin (Total And Unbound) In The Neonate Test System
Reason for recall: Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Field Safety Notice was sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on December 30, 2014 both in the United States and elsewhere for communication with affected customers. In addition, all affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on December 30, 2014. All affected customers outside the US will be provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. This notice informs consignees of the issue. Consignees are also asked to complete a field effectiveness check form and return it Siemens via fax (312) 275-7795.
Quantity in commerce: 2863 devices
Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Ivory Coast, Kazakhstan, Kuwait, Latvia, Lebanon, Lesotho, Lithuania, Luxembourg, Macedonia, Netherlands, New Caledonia, Norway, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Vatican City, Venezuela, White Russia/Belarus.
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1255-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1252-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-06
Z-1253-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-06
Z-1254-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-06
Z-1255-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-06

Product code MQM

K073537Class INeonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics / cleared 2008-06-27

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)