Anti-FITC-AP CISH Kit Label Bears Incorrect Expiration Date
Agilent Technologies is recalling 63 Anti-FITC-AP CISH Accessory Kits due to incorrect expiration dates on substrate vial labels, which may result in the use of expired materials.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III recall for a labeling error involving incorrect expiration dates on substrate vials. No illnesses or injuries have been reported. FDA Class III recalls are typically scored as 1 or 2; labeling errors fall under Moderate severity.
Plain-English summary
Agilent Technologies, Inc. is recalling 63 Anti-FITC-AP CISH Accessory Kits (Dako Omnis), Box A, because the labels on substrate vials contain incorrect expiration dates.
The affected kits were distributed in New York and Virginia. Kits carry model number K589911-2 with lot numbers 06586309 and 06646626. Associated vials have material number K859911-21512 with lot numbers 06646739 and 06586327 (UDI-DI code 0 5700571 11286 1).
The incorrect expiration dates prevent accurate identification of whether the substrate materials have expired. Users may unknowingly employ expired reagents in diagnostic procedures.
Customers should verify their kit lot numbers against the recall notice and contact Agilent Technologies, Inc. for information on replacement kits or other corrective measures.
The recalled product
- Product
- Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
- Manufacturer
- Agilent Technologies, Inc.
- Category
- Medical Device — Diagnostic Kit
- Hazard
- Affected units
- 63
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)
- 06646626
- Vial Material Number: K859911-21512 Lot Number: 06646739 Lot Number: 06586327
Distribution
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