CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report
Detector H. Pylori recalled by Immunostics
Immunostics is recalling Detector H. Pylori, distributed in California, Missouri. The recall was initiated on 25 Aug 2023 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-0702-2024
- FDA event ID
- 93646
- Recalling firm
- Immunostics, Eatontown, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Aug 2023
- FDA classified
- 10 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Aug 2023 | Recall initiated by company | |
| 10 Jan 2024 | Classified by FDA | +138 days |
| 17 Jan 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.
Product as listed by the FDA
Detector H. Pylori, Catalog Number IHP-30
Where it was distributed
Product distributed to CA and MO.
Questions about this recall
Is Detector H. Pylori recalled?
Yes. Immunostics recalled Detector H. Pylori on 25 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-0702-2024.
Why was it recalled?
Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.
Which lots are affected?
UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31
Where was it sold?
Product distributed to CA and MO.
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.
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |