Hologic Rapid for TLiIQ System Cassettes Recalled for Unapproved Material
Hologic is recalling Rapid for the TLiIQ System cassettes because they were manufactured with material from a new supplier before FDA approval of the change.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level involving temporary or medically reversible adverse health consequences or a remote probability of serious harm, without reported fatalities or hospitalizations.
Plain-English summary
Hologic, Inc. is recalling Rapid for the TLiIQ(R) System cassettes (Catalog number: 01200Q). The recall was initiated because the products were manufactured with material (A137 ascites) from a new supplier, SDIX, before the U.S. Food and Drug Administration (FDA) approved the change to use this specific material.
The affected products were distributed to customers in the United States, Guam, and Japan. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Customers who have purchased these cassettes should stop using them and contact Hologic, Inc. for further instructions on how to return or dispose of the product. No specific lot numbers or dates of manufacture are provided in the source text.
The recalled product
- Product
- Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
- Manufacturer
- Hologic, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- E7058
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Hologic, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Hologic, Inc.
See all →- ModerateHologic 3DIMENSIONS MAMMOGRAPHY SYSTEM medical device recall
FDA (Devices) · 2026-05-20
- SevereHologic Selenia Dimensions Mammography Systems Loose Internal Bolts
FDA (Devices) · 2026-05-20
- ModerateGenius Review Station Display Modified Outside Validated Configuration
FDA (Devices) · 2026-05-06
- HighHologic Aptima HPV assay may produce invalid or false negative results
FDA (Devices) · 2026-03-25
- HighBreast biopsy needles recalled over particulates that can enter tissue
FDA (Devices) · 2026-02-18
Same hazard · unapproved material
See all →- HighMedicina Oral Tip Syringe recalled for unapproved plunger material
FDA (Devices) · 2022-10-26
- ModerateHologic Recalls Rapid for TLiIQ System Kits Due to Unapproved Material
FDA (Devices) · 2018-02-28
- ModerateTeva Recalls Dextroamphetamine Tablets Due to CGMP Deviations
FDA (Drugs) · 2014-03-12
- ModerateTeva Recalls Hydroxyzine Pamoate Capsules Due to Unapproved Manufacturing Material
FDA (Drugs) · 2014-03-12
- ModerateAlterG Anti-Gravity Treadmill Accessory Shorts Recalled for Unapproved Material
FDA (Devices) · 2014-03-12