Food, drugs, devices › Hologic, Inc.
Device recall: Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
FDA enforcement event 78832 is a device recall by Hologic, Inc. of Sunnyvale, CA, initiated 29 Nov 2017 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 22 Aug 2018. Initiation: voluntary: firm initiated. Hologic, Inc. has 41 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Hologic, Inc., Sunnyvale, CA.
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."
Distribution
"United States (US), Guam (GU), Japan (JP)"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0676-2018 | Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200 | 165 kits | Class II | Terminated | 28 Feb 2018 |
| Z-0677-2018 | Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q | N/A | Class II | Terminated | 28 Feb 2018 |
Context
Other enforcement events for Hologic, Inc.
All 41 events for Hologic, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "United States (US), Guam (GU), Japan (JP)"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Aug 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.