Abbott Diagnostics probe conditioning solution recalled for cold chain storage failure
Abbott probe conditioning solution recalled after cold chain failure during transit. Products exposed to improper storage temperatures may produce 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 recall with no reported injuries, illnesses, or actual test result errors. The hazard is theoretical—improper storage conditions could affect diagnostic accuracy, but no patient harm has been documented. Per the rubric, risk-of-harm products without reported injury receive a score of 3.
Plain-English summary
Abbott Diagnostics Probe Conditioning Solution (Catalog No. 01L5640, GTIN 380740001193) for Architect Analyzer diagnostic systems is being recalled due to transit delays caused by severe thunderstorms.
During shipping, certain products were exposed to temperatures outside the manufacturer's recommended cold chain storage conditions. This failure could increase the probability of inaccurate test results or delayed test results, potentially affecting the reliability of diagnostic testing.
The recalled product was distributed nationwide to healthcare facilities in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Healthcare facilities should immediately verify the storage and condition of any affected product. Contact the recalling firm, McKesson Medical-Surgical Inc., or your supplier for guidance on product verification, replacement, or proper disposal.
The recalled product
- Product
- ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- inaccurate-test-results
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. 01L5640
- GTIN: 380740001193
- Order No. 46048552.
Distribution
Distributed nationwide across the United States.
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