Z-2926-2018Class II

Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the...

Name: Z-2926-2018 Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the...
Creator: Stanbio Laboratory, LP
Published: 2018-02-08
License: https://open.fda.gov/license/

Stanbio Laboratory / initiated 2018-02-08 / Terminated / root cause: manufacturing process

FDA source

Stanbio Laboratory, LP began a recall of Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic... on 2018-02-08. FDA classified it as Class II and gives the reason as "The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts". 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-2926-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-08
Posted: 2018-08-24
Terminated: 2020-09-04
Recalling firm: Stanbio Laboratory
Product: Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
Product code: GKR System, Hemoglobin, Automated
Reason for recall: The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recall was initiated via letter dated 2/7/2018 by first class mail letter on 2/8/2018 instructing the consignee to stop using the adapter if it is affected and it will be replaced.
Quantity in commerce: 2,804 devices
Distribution: Distribution was nationwide. There was military distribution and no government distribution. Foreign distribution was made to Bolivia, Malaysia, Mexico, Papua New Guinea, Paraguay, Philippines, and Suriname.
Product codes and lots: Serial number range of affected power adapters: 41800001-41804000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2926-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2926-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-24

Product code GKR

K081719Class IIStanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemStanbio Laboratory / cleared 2008-07-18

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)