HemoClue Hemotrol Control (Mckesson) – Cold Chain Disruption (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Brand
Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233
Lot Codes / Batch Numbers
Catalog No. 171001002, GTIN: 8718734960300, Order No. 46085136.
Products Sold
Catalog No. 171001002; GTIN: 8718734960300; Order No. 46085136.
Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233 is recalling HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL. due to transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled s. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Recommended Action
Per FDA guidance
An URGENT PRODUCT RECALL notification dated 4/21/25 was mailed to consignees. The notification instructs consignees to immediately examine their inventory and quarantine all product identified as subject to this recall action. Consignees are asked to return the completed response form to MMSQARecalls@McKesson.com and to destroy any quarantined devices. Questions about this recall can be directed to 1-800-688-8840 from 8:00 am to 5:00 pm Monday through Friday. If product has been further distributed, consignees are asked to forward the provided recall notice to those customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026