a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult...
FDA Device Recall #Z-1601-2022 — Class II — May 25, 2022
Recall Summary
| Recall Number | Z-1601-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 25, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Location | Richmond, VA |
| Product Type | Devices |
| Quantity | boxes: a. 20 b. 21 c. 4 |
Product Description
a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 100 Tests Model Number: 4487. c. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 50 Tests Model Number: 127-50ER
Reason for Recall
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Distribution Pattern
US Nationwide
Lot / Code Information
GTIN: a. 10612479219417; 20612479198368. b. 10612479226132; 20612479225569. c. 10612479226125; 20612479225552
Other Recalls from Mckesson Medical-Surgical Inc. Corpor...
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|---|---|---|---|
| Z-2337-2025 | Class II | Clearview Strep A Exact II Dipstick Respiratory... | Jul 30, 2025 |
| Z-1842-2025 | Class II | ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA)... | Apr 24, 2025 |
| Z-1837-2025 | Class II | ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/C... | Apr 24, 2025 |
| Z-1854-2025 | Class II | SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CO... | Apr 24, 2025 |
| Z-1846-2025 | Class II | ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) A... | Apr 24, 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.