McKesson Colorectal Cancer Screening Tests Recalled Due to Temperature Exposure
McKesson Medical-Surgical is recalling MMS - IMMUNOSTICS INC colorectal cancer screening test kits due to facility temperature excursions that may have reduced product effectiveness. The recall affects lots distributed between June and September 2021.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a cancer screening diagnostic test. No illnesses or injuries have been reported. Temperature exposure may have degraded test effectiveness, creating risk of false negative results. Risk-of-harm diagnostic products without reported injuries score 3 (High).
Plain-English summary
McKesson Medical-Surgical Inc. is recalling MMS - IMMUNOSTICS INC Rapid Test Kits for colorectal cancer screening. The affected products are Model 4487 (25-test and 100-test kits) and Model 127-50ER (50-test kit), distributed under the McKesson Consult brand.
The recall was initiated due to facility temperature excursions occurring from June through August 2021, prior to product delivery. These higher-than-recommended temperatures may have impacted the test kits' effectiveness as fecal occult blood tests (FOBT or FIT). All lots received between June 1, 2021, and September 30, 2021, are affected.
These products were distributed nationwide throughout the United States. The FDA has classified this as a Class II recall. Further details and product lot numbers are available in the official FDA recall notice.
The recalled product
- Product
- 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 Blo
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — Diagnostic Test
- Hazard
- temperature-exposure
- reduced-effectiveness
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- GTIN: a. 10612479219417
- 20612479198368. b. 10612479226132
- 20612479225569. c. 10612479226125
- 20612479225552
Distribution
Distributed nationwide across the United States.
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