Hologic Recalls Rapid for TLiIQ System Kits Due to Unapproved Material
Hologic is recalling 165 Rapid for the TLiIQ System kits because they were manufactured with a new material before FDA approval.
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. The hazard involves the use of an unapproved material from a new supplier, which is a regulatory and quality control issue. No illnesses, injuries, or deaths are reported in the source text, and the risk is not explicitly described as likely to cause serious health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Hologic, Inc. is recalling 165 kits of the Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200. The recall involves specific lot codes: K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, and E7082.
The recall was initiated because the Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier, SDIX. These products were distributed to customers before the FDA approved the change to use this specific material from the new supplier.
The affected products were distributed in the United States, Guam, and Japan. The source text does not specify consumer actions or report any illnesses or injuries associated with the use of these kits.
The recalled product
- Product
- Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
- Manufacturer
- Hologic, Inc.
- Hazard
- Affected units
- 165
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 (14)
- K6030
- L6010
- M6007
- M6032
- A7024
- A7056
- B7017
- B7042
- B7057
- C7053
- D7008
- D7043
- E7058
- E7082
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.
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