Abbott Diagnostics Calibrator Recall Due to Storage-Condition Failures
Abbott diagnostic calibrators may have been stored improperly during transit delays caused by thunderstorms, potentially affecting test accuracy. The units are being recalled to prevent inaccurate or delayed diagnostic 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 recall of a diagnostic calibrator with potential to cause inaccurate or delayed test results due to storage-condition failures. No test failures or diagnostic errors have been reported; the risk is theoretical.
Plain-English summary
Abbott Diagnostics ARCHITECT TOTAL T36X4ML Calibrator units are being recalled due to improper storage conditions during transit. These calibrators are used in clinical laboratories and diagnostic facilities.
Severe thunderstorms caused delays in product transit, resulting in units potentially being stored outside recommended temperature conditions. Improper storage could affect calibrator performance and increase the likelihood of inaccurate test results or delays in test processing at affected laboratories.
The affected units were distributed nationwide to healthcare and diagnostic facilities in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Product identification: Catalog Number 07K6402, GTIN 380740144845, and Order Number 46061983.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — Diagnostic
- Hazard
- improper-storage
- 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. 07K6402
- GTIN: 380740144845
- Order No. 46061983.
Distribution
Distributed nationwide across the United States.
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