Hologic Rapid for TLiIQ System Recall: FDA Approval Delayed

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Recalling firmHologic, Inc.1240 Elko Dr, N/A · Sunnyvale, CA 94089-2212

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Hologic is recalling Rapid for the TLiIQ System cassettes (catalog number 01200Q) because they were made with a new material supplier that the FDA hadn't approved yet. This could pose a minor risk if the material doesn't meet safety standards, but the recall doesn't require immediate action.

Why it’s dangerous

The cassettes were made with a new material (A137 ascites) from a supplier (SDIX) that the FDA had not approved before distribution. This could mean the material doesn't meet safety standards, but the risk is minor and unlikely to cause serious harm.

Who’s affected

Users of the Rapid for TLiIQ System cassettes with catalog number 01200Q are affected. Patients and healthcare providers using these cassettes for medical imaging are at the lowest risk.

How to tell if you have this one

Check for the catalog number 01200Q on the Rapid for TLiIQ System cassettes. The product was distributed to customers before FDA approval of the new material supplier.

Brand
Hologic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the catalog number 01200Q on the Rapid for TLiIQ System cassettes.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The cassettes were manufactured with a new material supplier (SDIX) that the FDA had not approved before distribution.

Is there an immediate risk to health?

The recall is for a low-risk situation as the material change did not cause serious injury or death.

Do I need to stop using these cassettes?

No immediate action is needed; the recall does not require stopping use.

Take action

Contact Hologic

We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0677-2018 — Hologic Hologic

Hello,

I own a Hologic that is covered by recall Z-0677-2018 from Hologic.

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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Where this comes from

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.

Official source: FDA Recall #Z-0677-2018 (November 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0677-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Hologic, Inc. recalls Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q

Lower-risk recall