CLASS III Device recall · Reported 10 Apr 2019 · FDA Enforcement Report
McKesson Consult Diagnostic Immunochemical Fecal Occult recalled
Cypress Medical Products is recalling McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers, distributed in 27 states. The recall was initiated on 27 Feb 2019 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1080-2019
- FDA event ID
- 82312
- Recalling firm
- Cypress Medical Products, Richmond, VA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Feb 2019
- FDA classified
- 30 Mar 2019
- Reported
- 10 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Feb 2019 | Recall initiated by company | |
| 30 Mar 2019 | Classified by FDA | +31 days |
| 10 Apr 2019 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Shipped to distribution centers located in AL, AR, AZ, CA, CO, FL, GA, HI, IL, KY, LA, MA, MN, MO, MS, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WA, and WI.
AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIllinoisKentuckyLouisianaMassachusettsMinnesotaMissouriMississippiNew HampshireNew JerseyNew YorkOhioPennsylvania
Questions about this recall
Why was it 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.
Which lots are affected?
All lots
Where was it sold?
Shipped to distribution centers located in AL, AR, AZ, CA, CO, FL, GA, HI, IL, KY, LA, MA, MN, MO, MS, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WA, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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