BD Microbiology MacConkey II Agar Media Storage Condition Recall
BD Microbiology MacConkey II Agar media may have been stored outside recommended temperature conditions due to transit delays from severe thunderstorms, potentially resulting in incorrect or delayed test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 of a medical device (diagnostic agar media). The source text states the failure "could increase the probability" of incorrect or delayed test results, but no illnesses, injuries, or actual adverse outcomes are reported, making this a precautionary recall with theoretical risk.
Plain-English summary
BD Microbiology MacConkey II Agar (100/CT) 21270 Media is being recalled by McKesson Medical-Surgical Inc. Corporate Office due to transit delays caused by severe thunderstorms that may have resulted in products being stored outside the recommended labeled storage conditions.
When agar media is not stored at the specified temperature conditions, the probability of incorrect or delayed test results increases. This could affect the reliability of microbiology testing performed using the affected product.
The affected product was distributed nationwide to the states of Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The product is identified by Catalog No. 221270, GTIN 10382902212703, and Order No. 45723808. 200 units of this product were affected.
If you have received this product and it may have been exposed to conditions outside the recommended storage range, contact McKesson Medical-Surgical Inc. Corporate Office for guidance on the affected units.
The recalled product
- Product
- BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 200
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. 221270
- GTIN: 10382902212703
- Order No. 45723808.
Distribution
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.
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