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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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. 07K6402
- GTIN: 380740144845
- Order No. 46061983.
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.
See all 32 products in this recall →Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · temperature excursion
See all →- ModerateCyclophosphamide injection vials recalled after a transportation temperature excursion
FDA (Drugs) · 2025-09-24
- ModerateRecombinate antihemophilic factor vials exposed to temperatures outside labeled storage
FDA (Drugs) · 2025-08-13
- ModerateXolair auto-injectors exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateXolair 75 mg syringes exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
Similar recalls
- HighPregnancy Test Control Set Recalled for Temperature Excursion Risk
FDA (Devices) · 2024-03-27
- HighBeckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
FDA (Devices) · 2026-04-29
- LowAbbott Recalls ARCHITECT Intact PTH Calibrators Due to Missing Dry Ice
FDA (Devices) · 2019-05-22
- ModerateLaboratory Control Material Recalled Due to Temperature Storage Excursion
FDA (Devices) · 2024-03-27
- HighAbbott Point of Care Control Device Recalled Due to Temperature Storage Failure
FDA (Devices) · 2024-03-27
- ModerateQMS Tacrolimus Calibrators Recalled for Quality Degradation from Improper Storage
FDA (Devices) · 2024-01-17