Z-0677-2018Class II

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

Name: Z-0677-2018 Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
Creator: Hologic, Inc.
Published: 2017-11-29
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2017-11-29 / Terminated / root cause: supplier

FDA source

Hologic, Inc. began a recall of Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q on 2017-11-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0677-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-29
Posted: 2018-02-21
Terminated: 2018-08-22
Recalling firm: Hologic, Inc.
Product: Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
Product code: LKV Enzyme Immunoassay, Fetal Fibronectin
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.
Root cause tag: supplier
FDA root cause: Mixed-up of materials/components
Action: Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx.
Distribution: United States (US), Guam (GU), Japan (JP)
Product codes and lots: E7058

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0677-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0676-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21
Z-0677-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21

Product code LKV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)