Dako EnVision FLEX+ Mouse High pH Kits Recalled for pH Error
Dako Denmark A/S is recalling 147 kits of EnVision FLEX+ Mouse, High pH (Link) because the Target Retrieval Solution has an incorrect pH level.
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. The hazard is a functional defect (incorrect pH) that may impact test results, but no injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity recall involving low-risk contamination or functional errors without reported harm.
Plain-English summary
Dako Denmark A/S is recalling 147 kits of EnVision FLEX+, Mouse, High pH (Link), Product No. K8002 and K8004. These products are intended for use in immunohistochemistry together with Autostainer Link Instruments. The recall covers specific lots: K8002 Lot no: 10112879 and K8004 Lot no: 10111463.
The recall was initiated because the pH of the Target Retrieval Solution in the kits measures 4-5 instead of the correct pH of 9.1. This deviation from the specified pH level may affect the performance of the immunohistochemistry procedure.
The affected products were distributed worldwide, including in the US, Canada, and Colombia. Users should stop using the affected kits and contact the manufacturer for further instructions or a replacement.
The recalled product
- Product
- EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
- Manufacturer
- Dako Denmark A/S
- Affected units
- 147
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 (1)
- K8002 Lot no: 10112879 K8004 Lot no: 10111463
Distribution
Distribution scope not specified by the agency.
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