Abbott Diagnostics Architect Progesterone Reagent Storage Condition Recall
Abbott Diagnostics Architect Progesterone (100 tests) reagent is being recalled due to transit delays during severe thunderstorms that may have caused storage 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 for a diagnostic reagent. No illnesses or injuries are reported in the source text. The hazard is a potential for incorrect or delayed test results due to storage exposure, which is a precautionary concern rather than a confirmed adverse event. This fits the "Moderate" category for low-risk issues without reported harm.
Plain-English summary
Abbott Diagnostics Architect Progesterone (100 tests) reagent, manufactured by McKesson Medical-Surgical Inc. Corporate Office, is being recalled due to transit delays of certain cold chain products caused by severe thunderstorms. During transit, these products may have been stored outside the recommended labeled storage conditions.
This storage condition failure could increase the probability of an incorrect test result or a delayed test result. The affected product has Catalog No. 07K7725, GTIN 380740014919, and Order No. 46048552.
The product was distributed nationwide in the following states: AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN, and WV. Customers who have received affected units should contact their healthcare provider or the manufacturer for guidance on whether their supply may have been impacted.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
- 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. 07K7725
- GTIN: 380740014919
- 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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