Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is...
FDA Device Recall #Z-1424-2021 — Class II — March 10, 2021
Recall Summary
| Recall Number | Z-1424-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 10, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Remel Inc |
| Location | Lenexa, KS |
| Product Type | Devices |
| Quantity | 408 units |
Product Description
Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
Reason for Recall
When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
Lot Numbers: 201334 Exp. 2021-01-21, 210892 Exp. 2021-02-03, 217048 Exp. 2021-02-10
Other Recalls from Remel Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0331-2023 | Class I | Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Ne... | Oct 20, 2022 |
| Z-0334-2023 | Class I | Thermo SCIENTIFIC, Sensititre STP6F, Gram Negat... | Oct 20, 2022 |
| Z-0330-2023 | Class I | Thermo SCIENTIFIC, Sensititre HPB1, Gram Negati... | Oct 20, 2022 |
| Z-0329-2023 | Class I | Thermo SCIENTIFIC, Sensititre GN7F, Gram Negati... | Oct 20, 2022 |
| Z-0327-2023 | Class I | Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram ... | Oct 20, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.