Abbott Diagnostics Vitamin D Calibrator Transit Storage Conditions Issue
The Abbott Diagnostics Architect Vitamin D 6-Level Calibrator was exposed to improper storage conditions during transit due to severe thunderstorms, which may result 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: This is an FDA Class II recall of a diagnostic calibrator where improper storage conditions create a risk of incorrect or delayed test results, which could harm patient care. The source explicitly states no illnesses or injuries have been reported, but the product is risk-of-harm (incorrect diagnostic results), placing it at High (score 3) per the rubric.
Plain-English summary
Abbott Diagnostics Architect Vitamin D 6-Level Calibrator units were subject to transit delays caused by severe thunderstorms. These delays may have caused the products to be stored outside the recommended labeled storage conditions.
This exposure to improper storage conditions could increase the probability of an incorrect test result or a delayed test result. The affected product was distributed nationwide to medical facilities in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Affected customers should contact their healthcare provider or diagnostic laboratory to determine whether test results from affected calibrator units require verification or re-testing.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- 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)
- Catalog No. 05P0202
- GTIN: 380740142742
- Order No. 46048552.
Distribution
Part of a larger recall action
This product is one of 32 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.
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