Abbott Diagnostics Probe Conditioning Solution Recall
Abbott Diagnostics Probe Conditioning Solution for Architect analyzers is being recalled due to cold chain failures during severe thunderstorms. Products may have been stored outside recommended conditions, risking 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 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 potential product performance degradation (incorrect or delayed test results) due to storage condition failure, but with no reported illnesses or injuries. The hazard is contingent and theoretical rather than confirmed.
Plain-English summary
Abbott Diagnostics Probe Conditioning Solution for Architect analyzers is being recalled nationwide. The product is distributed across AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN, and WV (Catalog No. 01L5640; GTIN: 380740001193; Order No. 46048552).
The recall was triggered by transit delays of certain cold chain products during severe thunderstorms. These delays may have caused the products to be stored outside the manufacturer's recommended labeled storage conditions.
This storage failure could increase the probability of an incorrect test result or a delayed test result when the product is used for diagnostic testing on Architect analyzers. Healthcare facilities and laboratories that received affected units should contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
- 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. 01L5640
- GTIN: 380740001193
- Order No. 46048552.
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.
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