—#206162

Product

Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mL

FDA product code: JJY — Multi-Analyte Controls, All Kinds (Assayed)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K972868
Affected lot / code info: Catalogue Number: 06F1201; UDI/DI: 54749000463; Lot No: 101164

Why it was recalled

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.

Root cause (FDA determination)

Storage

Action the firm took

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.

Recalling firm

Firm: Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Distribution

Distribution pattern: US Nationwide distribution in the states of AZ, PA and TX.

Timeline

Recall initiated: 2024-01-09
Posted by FDA: 2024-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206162. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.