Serrated Blade Applicator Kit recall
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro…
Why was Serrated Blade Applicator Kit recalled?
Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 3-22, UDI-DI: M5255526870
- Product
- Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro…
- Recalling firm
- Helena Laboratories, Corp.
- Quantity
- 32 units
- Distribution
- Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.
- Recall date
- June 28, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)