The Recall Desk
HighFDA (Devices)·Z-1830-2025·Announced 2025-06-04

HbA1c Test Kit Recalled Due to Cold Chain Storage Failure

Abbott HbA1c test kits were stored outside recommended cold chain conditions during transit delays caused by severe thunderstorms, risking incorrect or delayed test results. Eight units were affected.

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: FDA Class II recall without reported illnesses or injuries, with theoretical risk of test inaccuracy. Diagnostic test accuracy is critical in healthcare. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3 (High).

Plain-English summary

Abbott Rapid DX HbA1c Hemoglobin Afinion Glyctd test kits are being recalled due to improper storage during transit. Severe thunderstorms caused delays that resulted in the products being stored outside their recommended labeled storage conditions.

This storage failure increases the probability of an incorrect test result or a delayed test result. The affected units were distributed across Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.

The recalled product

Product
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Medical Device — Diagnostic Test Kit
Hazard
  • test-inaccuracy
  • delayed-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. 1116974
  • GTIN: 7070060014654
  • Order No. 46085136 & 46115470.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category