CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report
Stanbio AC power adapter for the HemoPoint H2 meter recalled
Stanbio Laboratory is recalling Stanbio AC power adapter for the HemoPoint H2 meter, distributed nationwide in the US. The recall was initiated on 8 Feb 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2926-2018
- FDA event ID
- 80562
- Recalling firm
- Stanbio Laboratory, Boerne, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Feb 2018
- FDA classified
- 24 Aug 2018
- Reported
- 5 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Feb 2018 | Recall initiated by company | |
| 24 Aug 2018 | Classified by FDA | +197 days |
| 5 Sep 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Stanbio AC power adapter for the HemoPoint H2 meter recalled?
Yes. Stanbio Laboratory recalled Stanbio AC power adapter for the HemoPoint H2 meter on 8 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-2926-2018.
Why was it recalled?
The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
Which lots are affected?
Serial number range of affected power adapters: 41800001-41804000
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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