BD Thioglycollate Medium Tubes Recalled Due to Transit Storage Conditions
Mckesson Medical-Surgical is recalling BD Microbiology Fluid Thioglycollate Medium tubes due to transit delays and storage outside recommended temperature conditions. The products may produce 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: FDA Class II medical device recall involving a storage condition failure with no reported illnesses or injuries. The potential for incorrect test results is theoretical rather than confirmed, and the issue was identified before widespread clinical use, consistent with precautionary recalls at the Moderate severity level.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling BD MICROBIOLOGY FLUID THIOGLYCOLLATE MEDIUM tubes (Catalog No. 221196, GTIN: 30382902211960). The product is a culture medium used in laboratory settings for microbiological testing. The recall affects 100-unit packages distributed nationwide to Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
The recall was initiated due to transit delays caused by severe thunderstorms that resulted in certain products being stored outside their recommended labeled storage conditions. These storage failures may compromise the product's integrity and testing reliability.
Products stored outside recommended temperature ranges may produce incorrect test results or delayed test results, potentially affecting the accuracy of laboratory diagnoses. Healthcare facilities, clinical laboratories, and other users of this product should verify they have not received affected units. If you have received this product, contact Mckesson Medical-Surgical or your supplier for further instructions on how to proceed.
The recalled product
- Product
- BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- test-result-inaccuracy
- test-delay
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. 221196
- GTIN: 30382902211960
- Order No. 44987370.
Distribution
Distributed nationwide across the United States.
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