Abbott Progesterone Diagnostic Reagent Recall Due to Cold Chain Failure
Abbott Diagnostics Architect Progesterone reagent units were affected by transit delays during severe thunderstorms, causing improper storage that could lead to incorrect 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 FDA Class II medical diagnostic device recall involves risk of inaccurate test results due to improper storage conditions, which could harm patient care through incorrect clinical decisions. The hazard is direct and significant, but no injuries or illnesses have been reported.
Plain-English summary
Abbott Diagnostics Architect Progesterone (100 tests) Reagent has been recalled due to transit delays caused by severe thunderstorms. During shipment, affected units were stored outside the manufacturer's recommended labeled storage conditions.
This storage failure could increase the probability of incorrect test results or delayed test results when the product is used. Diagnostic reagent accuracy is critical for proper patient care and clinical decision-making.
Affected units were distributed to the following states: Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Customers who received affected units should consult the manufacturer for guidance on product disposition and any necessary actions.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- cold-chain-failure
- test-inaccuracy
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
Distributed nationwide across the United States.
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