Abbott Diagnostics Architect Free T4 Calibrator Recall
Abbott Diagnostics Architect Free T4 Calibrator units may have been exposed to improper storage conditions due to transit delays from severe thunderstorms, potentially causing incorrect or delayed test results.
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 an FDA Class II medical device recall involving a diagnostic calibrator where improper storage could affect test accuracy. No illnesses or injuries are reported in the source text, but the hazard—potential incorrect or delayed diagnostic results—represents a risk of harm to patient care that warrants a High severity rating.
Plain-English summary
Abbott Diagnostics Architect Free T4 Calibrator units have been recalled due to transit delays caused by severe thunderstorms. These delays may have resulted in affected products being stored outside their recommended labeled storage conditions.
The failure to maintain proper storage conditions could increase the probability of incorrect test results or delayed test results. The affected products were distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Customers who have received affected units should contact their healthcare facility's laboratory director or the recalling manufacturer for further guidance on handling the products and any potential need for quality assurance measures.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- improper-storage
- test-accuracy-risk
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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