Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set Recall
Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set units may have been exposed to improper storage conditions during transit due to severe thunderstorms, which could result in 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 a diagnostic control product. No illnesses or injuries are reported in the source text; the hazard is a potential for incorrect or delayed test results due to storage conditions. The recall appears precautionary rather than based on confirmed product failures.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set (Catalog No. 138; GTIN: 742860100093; Order No. 45402895) distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
During transit, certain cold chain products experienced delays caused by severe thunderstorms. This weather event may have caused the products to be stored outside their recommended labeled storage conditions. Such exposure could compromise the integrity of the control set.
This storage failure could increase the probability of an incorrect test result or a delayed test result when the product is used. Healthcare providers and laboratories using this product should be aware of the potential for unreliable results.
Customers who have received affected units should contact Mckesson Medical-Surgical Inc. or the FDA with questions regarding their specific shipments.
The recalled product
- Product
- SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 1
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. 138
- GTIN: 742860100093
- Order No. 45402895.
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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