CLASS II ONGOING Device recall · Reported 31 Aug 2022 · FDA Enforcement Report
a. MMS - Immunostics INC McKesson Rapid Test Kit Consult recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling a. MMS - Immunostics INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening, distributed nationwide in the US. The recall was initiated on 25 May 2022 and the FDA has classified it as Class II.
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-1601-2022
- FDA event ID
- 90336
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 May 2022
- FDA classified
- 25 Aug 2022
- Reported
- 31 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Temperature Abuse
- Device type
- Test Kits & Diagnostics
Timeline
| 25 May 2022 | Recall initiated by company | |
| 25 Aug 2022 | Classified by FDA | +92 days |
| 31 Aug 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 100 Tests Model Number: 4487. c. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 50 Tests Model Number: 127-50ER
Where it was distributed
US Nationwide
Questions about this recall
Is a. MMS - Immunostics INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening recalled?
Yes. Mckesson Medical-Surgical Inc. Corporate Office recalled a. MMS - Immunostics INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening on 25 May 2022. The recall is Class II and its status is Ongoing. Recall number Z-1601-2022.
Why was it recalled?
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Which lots are affected?
GTIN: a. 10612479219417; 20612479198368. b. 10612479226132; 20612479225569. c. 10612479226125; 20612479225552
Where was it sold?
US Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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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