Abbott HIV Diagnostics Calibrator Recalled Due to Temperature Storage Excursion
Abbott diagnostics calibrators were exposed to improper storage temperatures during transit due to severe thunderstorms, which may cause incorrect or delayed HIV 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 involving temperature excursion of diagnostic calibrators, which are risk-of-harm products critical to test accuracy. No actual test failures, illnesses, or injuries have been reported; the risk is theoretical. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
The Abbott Diagnostics Architect HIV Combo 1X4ML Calibrator is being recalled due to transit delays caused by severe thunderstorms. These delays resulted in products being stored outside their recommended temperature conditions.
This storage temperature excursion could increase the probability of incorrect or delayed test results. Calibrators are critical control materials used to ensure diagnostic test accuracy.
The recall affects nationwide distribution in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Affected product identifiers: Catalog No. 02P3601, GTIN 380740003876, Order No. 46061983.
Healthcare facilities should verify storage conditions and assess any test results obtained using these calibrators. Contact McKesson Medical-Surgical Inc. for product replacement guidance.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- incorrect-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. 02P3601
- GTIN: 380740003876
- Order No. 46061983.
Distribution
Distributed nationwide across the United States.
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