Abbott Diagnostics HIV Combo Calibrator Affected by Cold Chain Exposure
Abbott Diagnostics ARCHITECT HIV COMBO Calibrator units may have been exposed to improper storage temperatures due to transit delays during severe thunderstorms, potentially affecting test accuracy.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a diagnostic calibrator exposed to out-of-specification storage conditions. No illnesses or injuries are reported; the hazard is a potential for incorrect test results, which is a theoretical risk without evidence of actual harm. This meets the threshold for Moderate severity.
Plain-English summary
Abbott Diagnostics ARCHITECT HIV COMBO 1X4ML Calibrator (Catalog No. 02P3601; GTIN 380740003876) is being recalled due to cold chain storage failures during transit.
Certain units were exposed to storage conditions outside the manufacturer's recommended temperature range due to severe thunderstorms causing transit delays. This exposure could increase the probability of incorrect or delayed test results.
The recalled product was distributed nationwide to the states of Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The product is manufactured by Mckesson Medical-Surgical Inc. Corporate Office.
Laboratories and healthcare facilities that received affected units should contact the recalling firm or consult product documentation for guidance on product lot verification and appropriate corrective actions.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML 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. 02P3601
- GTIN: 380740003876
- 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 · improper storage
See all →- ModerateFairhope Cold Brew Coffee Concentrate Recall Over Missing Refrigeration Label
FDA (Food) · 2026-06-24
- ModerateOrtho Clinical Diagnostics Total Bili-Alkp XT Reagent Recall
FDA (Devices) · 2025-06-04
- ModerateHemoCue HemoTrol High Control Product Recalled Due to Storage Conditions
FDA (Devices) · 2025-06-04
- ModerateAbbott Rapid DX Multi Analyte Control Affected by Storage Temperature Excursion
FDA (Devices) · 2025-06-04
- ModerateSekisui Diagnostics LLC Serum HCG Osomgenzme Control Set Recall
FDA (Devices) · 2025-06-04
Similar recalls
- HighAbbott Recalls Hemoglobin A1c Calibrators Due to Potential Test Bias
FDA (Devices) · 2020-04-15
- LowAbbott Recalls ARCHITECT Intact PTH Calibrators Due to Missing Dry Ice
FDA (Devices) · 2019-05-22
- HighAbbott Alinity m Diagnostic System Recalled for Incorrect Optical Calibration
FDA (Devices) · 2022-08-24
- HighAbbott Point of Care Control Device Recalled Due to Temperature Storage Failure
FDA (Devices) · 2024-03-27
- HighPregnancy Test Control Set Recalled for Temperature Excursion Risk
FDA (Devices) · 2024-03-27
- HighAbbott ICT Serum Calibrator Recalled for Inaccurate Potassium Results
FDA (Devices) · 2015-07-08