Abbott Diagnostics Architect Total T36X4ML Calibrator Cold Chain Excursion
Abbott Diagnostics Architect Total T36X4ML Calibrator units experienced transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially resulting in 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: FDA Class II device recall where a storage/handling failure could impair diagnostic accuracy. The source explicitly identifies risk of incorrect or delayed test results, which represents a risk of harm to patients relying on accurate diagnostic information, even though no reported illnesses or injuries are stated in the source text.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Abbott Diagnostics Architect Total T36X4ML Calibrator (Catalog No. 07K6402) due to transit delays caused by severe thunderstorms. These weather events may have caused affected units to be stored outside the recommended labeled storage conditions.
When calibrator units are stored outside the recommended temperature range, the probability of an incorrect test result or a delayed test result may increase. This could affect the reliability of diagnostic testing using this calibrator.
The affected product was distributed nationwide to customers in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Customers who received affected units should contact McKesson Medical-Surgical Inc. or Abbott Diagnostics for guidance on product replacement or verification.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- incorrect-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. 07K6402
- GTIN: 380740144845
- Order No. 46061983.
Distribution
Distributed nationwide across the United States.
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