CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report
Ortho Clinical Diagnostics Inc Vitros Bun recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Ortho Clinical Diagnostics Inc Vitros Bun (60/cr 5cr/PK) Orclnl Reagent, distributed nationwide in the US. The recall was initiated on 24 Apr 2025 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-1837-2025
- FDA event ID
- 96752
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Apr 2025
- FDA classified
- 27 May 2025
- Reported
- 4 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Apr 2025 | Recall initiated by company | |
| 27 May 2025 | Classified by FDA | +33 days |
| 4 Jun 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
Where it was distributed
US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
Nationwide AlabamaArkansasIllinoisKansasMontanaNorth CarolinaNew JerseyOregonSouth CarolinaTennesseeWest Virginia
Questions about this recall
Is Ortho Clinical Diagnostics Inc Vitros Bun (60/cr 5cr/PK) Orclnl Reagent recalled?
Yes. Mckesson Medical-Surgical Inc. Corporate Office recalled Ortho Clinical Diagnostics Inc Vitros Bun (60/cr 5cr/PK) Orclnl Reagent on 24 Apr 2025. The recall is Class II and its status is Ongoing. Recall number Z-1837-2025.
Why was it recalled?
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Which lots are affected?
Catalog No. 8102204; GTIN: 10758750004362; Order No. 46047530.
Where was it sold?
US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
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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