Reported Feb 28, 2018 · Terminated
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
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 number01200Q
- Lot codes and dates
- E7058
- Amount recalled
- N/A
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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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