Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Mediu...
FDA Device Recall #Z-2038-2023 — Class II — May 31, 2023
Recall Summary
| Recall Number | Z-2038-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 31, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Remel, Inc |
| Location | Lenexa, KS |
| Product Type | Devices |
| Quantity | 1,296 packs |
Product Description
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
Reason for Recall
The test medium may not perform as intended.
Distribution Pattern
Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution.
Lot / Code Information
REF R04033 lot numbers and expiration dates: Lot 619859 Exp. 2023-03-23, Lot 629086 Exp. 2023-03-31, Lot 629087 Exp. 2023-03-31, Lot 631001 Exp. 2023-04-11, Lot 634496 Exp. 2023-04-18, Lot 635369 Exp. 2023-04-19, Lot 645950 Exp. 2023-05-11, Lot 648004 Exp. 2023-05-18, and Lot 651372 Exp. 2023-05-23. UDI-DI #00848838004476. REF R01503 lot numbers and expiration dates: Lot 623548 Exp. 2023-03-28, Lot 631958 Exp. 2023-04-12, Lot 641527 Exp. 2023-05-02, Lot 644542 Exp. 2023-05-09, and Lot 648125 Exp. 2023-05-16. UDI-DI #00848838001932.
Other Recalls from Remel, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1474-2026 | Class II | Campy CVA Medium 100/PK, R01272 | Feb 5, 2026 |
| Z-0585-2026 | Class II | 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 ... | Nov 12, 2025 |
| Z-2224-2025 | Class II | Strep Selective II Agar, Product Number R01859 | Jul 11, 2025 |
| Z-2223-2025 | Class II | Blood Agar,5% Sheep Blood 100/PK, Product Numbe... | Jul 11, 2025 |
| Z-2225-2025 | Class II | Blood/EMB, Levine 100/PK, Product Number R02041 | Jul 11, 2025 |
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.