CLASS II Device recall · Reported 28 Feb 2018 · FDA Enforcement Report

Rapid for the TLiIQ(R) System, Hologic(R) recalled

Hologic is recalling Rapid for the TLiIQ(R) System, Hologic(R). The recall was initiated on 29 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesK6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082

Quantity recalled165 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0676-2018
FDA event ID: 78832
Recalling firm: Hologic, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 29 Nov 2017
FDA classified: 21 Feb 2018
Reported: 28 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Nov 2017	Recall initiated by company
21 Feb 2018	Classified by FDA	+84 days
28 Feb 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200

Where it was distributed

United States (US), Guam (GU), Japan (JP)

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082

Where was it sold?

United States (US), Guam (GU), Japan (JP)

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 78832

Reported	Class	Recall	Company	Reason	Where
28 Feb 2018	CLASS II	Rapid for the TLiIQ(R) System, Hologic(R) recalled	Hologic	Other	CA

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