Entopsis recalls PCRopsis Reagent Buccal (IVD REF 282001) due to misleading label statements. Affected units include Lot 4, Exp. 08/2023. No action required as the hazard is labeling-related.
Presence of misleading label statements on the product label.
Entopsis is recalling PCRopsis Reagent Buccal (IVD REF 282001) because the product label contains misleading statements. This labeling issue does not pose a safety risk to users and requires no action.
The product label contains misleading statements about the product's use and specifications. This could lead to confusion about how to properly use the reagent but does not cause physical harm or injury.
Users of PCRopsis Reagent Buccal (IVD REF 282001) who purchased the product with Lot number 4, expired 08/2023. No one is at significant risk from this labeling issue.
Check for the product name 'PCRopsis Reagent Buccal', IVD REF 282001, and Lot number 4 with expiration date 08/2023. The product is used for extraction-free PCR from buccal swabs without transport medium.
Review the product label for the lot number and expiration date to confirm if it matches Lot 4, Exp. 08/2023.
No action is required as the hazard is labeling-related and does not pose a safety risk.
No action is needed. The product label has misleading statements but this does not affect safety.
The recall is due to misleading label statements, not a physical hazard. No injury risk exists.
We’ve drafted a message you can send Entopsis to request your refund or repair — edit it as you like.
Subject: Recall Z-1296-2023 — Entopsis Entopsis Hello, I own a Entopsis that is covered by recall Z-1296-2023 from Entopsis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
