Abbott Diagnostics Architect Free T4 Calibrator Recall Due to Storage Temperature Excursion
This diagnostic calibrator may have been exposed to improper storage temperatures during transit due to severe thunderstorms, potentially affecting test result accuracy. Affected units were distributed to healthcare facilities across ten states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II precautionary recall due to potential storage temperature excursion during transit. No illnesses, injuries, or actual test failures have been reported; the hazard is theoretical based on storage condition exposure.
Plain-English summary
Abbott Diagnostics' Architect Free T4 Calibrator is a medical device used to calibrate diagnostic testing equipment in clinical laboratories. Units were manufactured by Mckesson Medical-Surgical Inc. and distributed nationwide to facilities in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
During shipment, severe thunderstorms caused transit delays that exposed certain units to temperatures outside the manufacturer's labeled storage conditions. Calibrators must be stored within specified temperature ranges to ensure accuracy and reliability of test results.
When stored outside recommended temperature ranges, there is an increased risk of incorrect test results or delayed test results. The recall was issued to prevent diagnostic equipment from being calibrated with potentially compromised calibrators that may not perform to specification.
Healthcare facilities that received affected units should verify receipt dates and catalog numbers against the recall notice. Facilities should review laboratory results obtained using these calibrators and consider verification steps if test accuracy concerns arise.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- incorrect-test-result
- delayed-test-result
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)
- Catalog No. 07K6502
- GTIN: 380740081034
- Order No. 46048552.
Distribution
Distributed nationwide across the United States.
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