Z-1372-2022Class II

epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of...

Name: Z-1372-2022 epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2022-06-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-06-01 / Open, Classified

FDA source

Siemens Healthcare Diagnostics Inc began a recall of epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous... on 2022-06-01. FDA classified it as Class II and gives the reason as "Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1372-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-01
Posted: 2022-07-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
FDA root cause: Under Investigation by firm
Action: Siemens has issued an Urgent Medical Device Correction letter POC 22-010.A.US via FedEx beginning on June 1, 2022. An Urgent Field Safety Notice (UFSN) was issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities. Letter states reason for recall, health risk and action to take: Please dispose any inventory of epoc BGEM test card lot 11-22005-50 currently in your possession in accordance with local and state disposal requirements. You may request free of charge replacement product from your local Siemens or distributor office. Please review your inventory of this product and assess your laboratory s replacement needs. Please use an epoc BGEM test card from another unaffected lot. Review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check and Product Replacement Form attached to this letter. Please retain this letter with your laboratory records and forward it to those who may have received this product. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 263 Boxes
Distribution: AL CA CO FL IA ID KS NM OK TX
Product codes and lots: UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1372-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1372-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12

Product code CHL

K192240Class IIRAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. / cleared 2020-03-27

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