Hologic recalls Rapid cassettes (catalog 01200) due to unapproved material from a new supplier. This could pose risks if used without FDA approval. Affected users should check their model numbers.
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.
Hologic is recalling Rapid cassettes for the TLiIQ System because they were made with a new material that the FDA hasn't approved yet. This could lead to safety issues if the cassettes are used without proper approval.
The cassettes were manufactured with a material (A137 ascites) from a new supplier (SDIX) that the FDA did not approve before distribution. This unapproved material change could lead to safety issues if the cassettes are used without proper regulatory oversight.
Users of the Rapid cassettes (catalog 01200) for the TLiIQ System are affected. Medical professionals using these cassettes in imaging procedures are most at risk.
Check for the catalog number 01200 on the Rapid cassettes. The affected models include K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, and E7082.
Look for the catalog number 01200 on the Rapid cassette packaging or label.
The cassettes were manufactured with a new material (A137 ascites) from a supplier (SDIX) that the FDA did not approve before distribution.
The affected models include K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, and E7082.
The recall record does not specify a remedy, so check with Hologic directly for guidance.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-0676-2018 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-0676-2018 from Hologic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
