Reported Apr 10, 2019 · Terminated
McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO,…
Cypress Medical Products LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cypress Medical Products LLC · 9954 Mayland Dr · Richmond, VA · 23233-1464
Is this the product you have?
- 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
- Lot codes and dates
- All lots
- Amount recalled
- 1165 cases
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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