Sekisui HCG Serum Control Set Recalled for Improper Transit Storage
A Sekisui Diagnostics HCG control set used in clinical laboratories may have been exposed to improper storage temperatures during transit due to severe thunderstorms. This exposure could result in incorrect or delayed test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm diagnostic product with no reported illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High (3) score; while the control set poses a potential risk to test accuracy in clinical diagnostics, the hazard is theoretical and no actual harm has been documented.
Plain-English summary
The SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET is a diagnostic control reagent used in clinical laboratories to verify the accuracy of human chorionic gonadotropin (HCG) test systems. The product (Catalog No. 138; GTIN: 742860100093) is manufactured and distributed by Mckesson Medical-Surgical Inc.
A recall has been issued because certain units may have experienced transit delays during distribution due to severe thunderstorms. These environmental conditions may have caused the products to be stored outside their recommended labeled storage conditions, potentially compromising the integrity and reliability of the control material.
The recall affects units distributed to clinical laboratories in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Laboratories that have received this product should identify affected units and contact Mckesson Medical-Surgical Inc. for replacement units or further instructions regarding their use.
Storage outside the recommended temperature range could increase the probability of obtaining incorrect test results or delayed results when these controls are used to verify laboratory testing systems. This could compromise the reliability of HCG testing and related quality assurance procedures in clinical settings.
The recalled product
- Product
- SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- incorrect-test-result
- delayed-test-result
- improper-storage
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
Distributed nationwide across the United States.
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