McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-C...
FDA Device Recall #Z-1080-2019 — Class III — February 27, 2019
Recall Summary
| Recall Number | Z-1080-2019 |
| Classification | Class III — Low risk |
| Date Initiated | February 27, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cypress Medical Products LLC |
| Location | Richmond, VA |
| Product Type | Devices |
| Quantity | 1165 cases |
Product Description
McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178¿CK30
Reason for Recall
Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.
Distribution Pattern
Shipped to distribution centers located in AL, AR, AZ, CA, CO, FL, GA, HI, IL, KY, LA, MA, MN, MO, MS, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WA, and WI.
Lot / Code Information
All lots
Other Recalls from Cypress Medical Products LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3184-2024 | Class II | BinaxNOW Respiratory Strep A Test Kit, CLIA Wai... | Aug 20, 2024 |
| Z-3185-2024 | Class II | Acceava Respiratory Strep A, CLIA Waived, Catal... | Aug 20, 2024 |
| Z-3154-2024 | Class II | General Purpose Syringe McKesson 60 mL Luer Loc... | Aug 6, 2024 |
| Z-2940-2024 | Class II | McKesson Syringe 60CC, Luer Lock Tip, Sterile, ... | Jul 24, 2024 |
| Z-2473-2021 | Class II | McKesson Lap Sponge, X-Ray Detectable 12"x 12"... | Aug 11, 2021 |
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.