The Recall Desk
HighFDA (Devices)·Z-1314-2024·Announced 2024-03-27

Abbott Point of Care Control Device Recalled Due to Temperature Storage Failure

Abbott's i-STAT Level 1 control device is recalled because a refrigerator temperature excursion on January 8, 2024, could cause incorrect or delayed test results. The walk-in storage unit failed, causing temperatures to fall below the required range of 35.6-46.4°F.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device where injury has not yet been reported. The temperature excursion could cause incorrect or delayed test results, which represents a functional failure of a critical laboratory device. No illnesses or injuries have been reported, which prevents a higher classification.

Plain-English summary

Abbott's Point of Care Control i-STAT Level 1 control device is being recalled. The recall was triggered by a mechanical failure in a walk-in refrigerator on January 8, 2024, that caused storage temperatures to fall below the validated range of 35.6 to 46.4 degrees Fahrenheit (2 to 8 degrees Celsius) for up to 60 minutes.

This temperature excursion could increase the probability of incorrect test results or delayed test results. The control device is used in point-of-care testing and relies on proper storage conditions to maintain accuracy.

The affected lot is Lot No. 101164 (Catalog Number 06F1201). The product was distributed nationwide in Arizona, Pennsylvania, and Texas.

The recalled product

Product
Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Medical Device — Point-of-Care Testing Control
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Catalogue Number: 06F1201
  • UDI/DI: 54749000463
  • Lot No: 101164

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

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Same hazard · temperature excursion

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