Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
Reported: March 27, 2024 Initiated: January 9, 2024 #Z-1314-2024
Product Description
Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
Reason for Recall
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.
Details
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Units Affected
- 1 unit
- Distribution
- US Nationwide distribution in the states of AZ, PA and TX.
- Location
- Richmond, VA
Frequently Asked Questions
What product was recalled? ▼
Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 1 unit.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2024. Severity: Moderate. Recall number: Z-1314-2024.
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