Z-2930-2018Class II

RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for...

Name: Z-2930-2018 RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-07-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-07-16 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test... on 2018-07-16. FDA classified it as Class II and gives the reason as "Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than...". 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-2930-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-16
Posted: 2018-08-24
Terminated: 2020-06-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
Product code: GKR System, Hemoglobin, Automated
Reason for recall: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Siemens Healthineers, sent an "Urgent Field Safety Notice" letter dated 7/2018 to its customers via FedEx on 7/18/18. The recall communication alerts customers that therapeutic levels of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas Systems identified in the letter. Customer are advised to review the letter with their Medical Director, and complete and return the effectiveness check form within 7 days. Customers may continue to use their devices. Siemens is not recommending a review of previously generated results. The firm stated that they will be revising the Operators Guides for the 500 and 1200 series Operator's Guides with information on the interfering substance. The RapidPoint 405 Operator's Guide will not be revised due to the discontinuation of the manufacture of this analyzer. However, users should remain aware of the issue with hydroxocobalamine interference. Customers with questions were directed to contact their local Siemens technical support representative or Safety Officer (POC) at 800-441-9250 or email to: [email protected].
Quantity in commerce: 2357
Distribution: Nationwide distribution. Worldwide foreign distribution.
Product codes and lots: All units affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2930-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2927-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-24
Z-2928-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-24
Z-2929-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-24
Z-2930-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-24

Product code GKR

K031560Class IIBayer Rapidlab 1200 SystemBayer Healthcare, LLC / cleared 2003-12-17

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)