Recall Z-1080-2019— Cypress Medical Products LLC

Name: FDA recall Z-1080-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-27

Class III · Terminated

Class III FDA medical device recall by Cypress Medical Products LLC, initiated 2019-02-27, terminated 2021-05-21. It names one FDA 510(k) clearance: K041202. 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. Reason: 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..

Recalling firm: Cypress Medical Products LLC
Classification: Class III
Status: Terminated
Initiated: 2019-02-27
Terminated: 2021-05-21
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K041202 — HEMOSURE ONE-STEP FECAL OCCULT BLOOD TESTW.H.P.M., Inc.·cleared 2004-08-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.