Unrated Medical device recall · FDA · Published November 29, 2017

Hologic Rapid for TLiIQ System: FDA-approved material change risk

Hologic recalls Rapid cassettes (catalog 01200) due to unapproved material from a new supplier. This could pose risks if used without FDA approval. Affected users should check their model numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0676-2018Medical device Hologic ›

Recall notice

Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Hologic is recalling Rapid cassettes for the TLiIQ System because they were made with a new material that the FDA hasn't approved yet. This could lead to safety issues if the cassettes are used without proper approval. Read more at govinfonow.com/recall/72423-hologic-rapid-for-tliiq-system-fda-approved-material-change-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72423-hologic-rapid-for-tliiq-system-fda-approved-material-change-risk · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0676-2018

Cite this page

“Hologic Rapid for TLiIQ System: FDA-approved material change risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72423-hologic-rapid-for-tliiq-system-fda-approved-material-change-risk. Based on FDA recall #Z-0676-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0676-2018%22&limit=1).

The FDA announced on November 29, 2017, that Hologic, Inc. voluntarily recalled Rapid for the TLiIQ(R) System due to manufacturing hazards. The agency stated the recall was initiated by the firm.

How to tell if you have it

Brand: Hologic
Product: Rapid for the TLiIQ(R) System, HOLOGIC(R)
Catalog number: 01200
Lot codes: K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082
Quantity: 165 kits

The hazard

GovInfoNow's records show that Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before the FDA approved the change to use the material from SDIX.

Context

GovInfoNow's records show Hologic, Inc. has issued 30 other recalls since June 27, 2017. Other recent recalls include a March 23, 2026 recall of Hologic Genius Review Station Displays for user modification risks and an April 8, 2026 recall of Hologic 3D Mammography Systems for loose bolts. Similar product recalls in February 2026 involved Medline ARTHROGRAM TRAY rescinded clearances and Medline Convenience Kits with unapproved syringes.

How to tell if you have this one

Check for the catalog number 01200 on the Rapid cassettes. The affected models include K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, and E7082.

Brand
Hologic
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
United States (US), Guam (GU), Japan (JP)

Recall number	Product, codes & lots	Quantity
Z-0676-2018	Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200; K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082	165 kits
Z-0677-2018	Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q; E7058	N/A

Based on the official FDA remedy

What to do — step by step

Check Product Model
Look for the catalog number 01200 on the Rapid cassette packaging or label.

How this recall unfolded

Recall timeline

FDA terminated this recall 9 months after the firm started it.

Nov 29, 2017Firm started the recall
Feb 21, 2018FDA classified it Class II
Feb 28, 2018Published in FDA’s Enforcement Report
Aug 22, 2018FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/72423-hologic-rapid-for-tliiq-system-fda-approved-material-change-risk">Hologic Rapid for TLiIQ System: FDA-approved material change risk (GovInfoNow)</a>

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-0676-2018 (November 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0676-2018 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.