McKesson Consult Diagnostic Fecal Occult Blood Test Recalled for Packaging Issues
Cypress Medical Products LLC is recalling McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Tests because the packaging is too similar to other products, leading to a denial of CLIA waiver approval.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a packaging similarity leading to a regulatory waiver denial, not a direct safety hazard like contamination or malfunction.
Plain-English summary
Cypress Medical Products LLC is recalling 1,165 cases of McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Tests. The affected products include part numbers 178-CK30T, 178-CT30, 178-TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, and 178-CK30. The recall covers all lots of these specific part numbers.
The recall was initiated because the FDA denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval for the products. The agency determined that the packaging was too similar to domestically sourced products operating under the same branded label, which could lead to confusion.
The products were shipped to distribution centers in Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. Users should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Cypress Medical Products LLC
- Category
- Medical Device — Diagnostic Test
- Affected units
- 1,165
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 (1)
- All lots
Distribution
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