The Recall Desk
ModerateFDA (Devices)·Z-1837-2025·Announced 2025-06-04

ORTHO CLINICAL DIAGNOSTICS VITROS BUN Reagent Recall Nationwide

ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN clinical reagent is being recalled due to transit delays caused by severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving potential laboratory test inaccuracy due to storage-condition deviation. No reported illnesses or injuries are stated in the source text, and the hazard is precautionary rather than confirmed. The issue arises from a one-time environmental event (thunderstorms) affecting cold chain storage, making this a moderate voluntary precautionary recall.

Plain-English summary

Mckesson Medical-Surgical Inc. is recalling ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) reagent (Catalog No. 8102204; GTIN: 10758750004362; Order No. 46047530). The recall was initiated because certain cold chain products experienced transit delays due to severe thunderstorms, which may have caused the products to be stored outside the recommended labeled storage conditions.

This failure in proper storage could increase the probability of an incorrect test result or a delayed test result. The product was distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.

Healthcare facilities and laboratories that received affected products should review their records for the product codes listed above. Consult ORTHO CLINICAL DIAGNOSTICS or your supplier for instructions on product handling or replacement.

The recalled product

Product
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Medical Device — Clinical Laboratory Reagent
Hazard
Affected units
60

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Catalog No. 8102204
  • GTIN: 10758750004362
  • Order No. 46047530.

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 32 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

Related recalls

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

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