Cypress Medical Products recalls McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Tests (part numbers 178-CK30T, 178-CT30, etc.) due to FDA CLIA waiver denial from packaging similarities to domestic products.
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.
Cypress Medical Products is recalling certain McKesson Consult fecal occult blood tests because their packaging is too similar to domestically sourced products, which led to the FDA denying CLIA waiver approval. This means the tests may not be legally used in clinical labs without proper regulatory clearance.
The tests' packaging is too similar to products made domestically under the same brand label. This caused the FDA to deny CLIA waiver approval, meaning the tests cannot be legally used in clinical labs without proper regulatory clearance.
Users of these fecal blood tests for clinical lab use are affected. Lab technicians and healthcare providers who rely on these tests for diagnostic purposes are most at risk due to regulatory non-compliance.
Check for part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, or 178¿CK30 on the packaging. All lots are included in this recall.
Identify the part number on the packaging to confirm if it matches the recalled items.
The FDA denied CLIA waiver approval because the packaging is too similar to domestically sourced products under the same branded label.
Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, and 178¿CK30.
The recall does not specify a stop-use instruction, but the products are not legally approved for clinical lab use without FDA clearance.
We’ve drafted a message you can send Cypress Medical Products to request your refund or repair — edit it as you like.
Subject: Recall Z-1080-2019 — Cypress Medical Products Cypress Medical Products Hello, I own a Cypress Medical Products that is covered by recall Z-1080-2019 from Cypress Medical Products. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
