Abbott Alkaline Wash Recall Due to Cap Leaking and Crystallization
Abbott Laboratories is recalling Alkaline Wash cleaning solution for Abbott Architect analyzers due to product leaking from the cap and crystallization around the cap.
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: The recall is classified as FDA Class II, but the specific defect (leaking and crystallization) is a packaging/integrity issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Laboratories is recalling Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. The product is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. The recall involves 8,868 units of Lot number 49059UN14, which has an expiration date of 04-MAR-2016.
The recall was initiated because the product is leaking from the cap and crystallization was noted as present around the cap. This issue affects the integrity of the container and the product within.
The product was distributed worldwide, including the United States, Mexico, Canada, and numerous other countries. Users of the Abbott Architect analyzers should check their inventory for this specific lot number and stop using the product if it matches the recalled description.
The recalled product
- Product
- Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.
- Manufacturer
- Abbott Laboratories
- Hazard
- Affected units
- 8,868
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 (2)
- Lot number 49059UN14
- Expiration data 04-MAR-2016.
Distribution
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