Abbott Diagnostics VitaminD Calibrator Recalled for Cold Chain Storage Excursion
Abbott Diagnostics VitaminD Calibrator units may have been exposed to improper storage temperatures during transit delays caused by severe thunderstorms. This could result in inaccurate 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 device recall. While no illnesses or injuries have been reported and the hazard is theoretical based on potential exposure to improper storage conditions, the device's function in clinical diagnostics means that inaccurate results could have clinical consequences.
Plain-English summary
Abbott Diagnostics Architect VitaminD 6Level Calibrator is a medical device used to calibrate vitamin D testing equipment in clinical laboratories. The device is designed to maintain accuracy when stored within specific temperature ranges.
Some units distributed nationwide were exposed to storage temperatures outside the manufacturer's recommended conditions due to transit delays during severe thunderstorms. This exposure could increase the probability of incorrect or delayed test results.
The affected product was distributed across Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- 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. 05P0202
- GTIN: 380740142742
- Order No. 46048552.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03