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Terminated

Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200

FDA Recall Z-0676-2018 · Posted None

Recalling FirmHologic, Inc.
Recall StatusTerminated
Product CodeLKV
Date Initiated2017-11-29
Date Terminated2018-08-22
Product Quantity165 kits

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.

Firm Action

Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx.

Root Cause

Mixed-up of materials/components

Distribution Pattern

United States (US), Guam (GU), Japan (JP)

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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