Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Reported: February 28, 2018 Initiated: November 29, 2017 #Z-0676-2018
Product Description
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Reason for Recall
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.
Details
- Recalling Firm
- Hologic, Inc.
- Units Affected
- 165 kits
- Distribution
- United States (US), Guam (GU), Japan (JP)
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200. Recalled by Hologic, Inc.. Units affected: 165 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2018. Severity: Moderate. Recall number: Z-0676-2018.
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