Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported April 10, 2019
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
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 th…
Cypress Medical Products LLC recalled McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30… - a low-severity action.
McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30… was recalled by Cypress Medical Products LLC in April 10, 2019. Reason: Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the…. Check the official notice for the remedy. Verify recall #Z-1080-2019 with the FDA Devices before acting.
The recall
Cypress Medical Products LLC issued this low-severity FDA Devices recall-Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the….
- Low
- severity level
- Class III
- classification
- April 10, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1080-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1080-2019) was formally reported on April 10, 2019, with the manufacturer initiating the action on February 27, 2019. It is classified under Low severity (Class III), with a current status of Terminated. Cypress Medical Products LLC is listed as the recalling firm, operating out of Richmond, VA. Federal records list the affected scope as 1165 cases.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1165 cases
Related Recalls
6
6 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1080-2019 |
| Date reported | April 10, 2019 |
| Date initiated | February 27, 2019 |
| Recalling firm | Cypress Medical Products LLC |
| Firm location | Richmond, VA |
| Affected scope | 1165 cases |
| Distribution | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1080-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cypress Medical Products LLC. Units affected: 1165 cases.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2019. Severity: Low. Recall number: Z-1080-2019.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1080-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 10, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.