Recall archive / FDA device enforcement
Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL — FDA record Z-1315-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 9, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- 2 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1315-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalogue Number: 06F1401; UDI/DI: 54749000661; Lot No: 121164; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of AZ, PA and TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 27, 2024
- Recall initiation date
- Jan 9, 2024
- Center classification date
- Mar 19, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.