Z-1601-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2022
- Initiation Date
- May 25, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
Code Information
GTIN: a. 10612479219417; 20612479198368. b. 10612479226132; 20612479225569. c. 10612479226125; 20612479225552