Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233 Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mL Recall
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
Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mL
Brand
Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233
Lot Codes / Batch Numbers
Catalogue Number: 06F1201, UDI/DI: 54749000463, Lot No: 101164
Products Sold
Catalogue Number: 06F1201; UDI/DI: 54749000463; Lot No: 101164
Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233 is recalling Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mL due to Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the val. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
Recommended Action
Per FDA guidance
McKesson notified customers by phone January 9, 2024 with a follow-up call January 17, 2024 instructing customers of three scenarios based upon the products they received and the investigation in conjunction with relevant manufacturer. The firm also sent Urgent Product Recall Notifications via email on February 8, 2024 instructing customers to immediately examine inventory and quarantine all affected devices, complete and return the provided response form to MMSQRCProductReviews@Mckesson.com, and notify customers who you have further distributed recalled devices to of this recall and to segregate and quarantine any devices they have on hand. Replacement products will be provided and may have the same lot number(s) as the recalled items but are not affected by the recall and are acceptable for use. Customers with questions can contact McKesson directly by phone at (800) 688-8840. Representatives are available Monday to Friday, 8:00 am to 5:00 pm PST.
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