Reported Feb 28, 2018 · Terminated
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc. · 1240 Elko Dr · Sunnyvale, CA · 94089-2212
Is this the product you have?
- Rapid for the TLiIQ(R) System, HOLOGIC(R)
- Catalog number01200
- Lot codes and dates
K6030L6010M6007M6032A7024A7056B7017B7042B7057C7053D7008D7043E7058E7082
- Amount recalled
- 165 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Hologic, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.