medical MODERATE Updated 2018-02-28

Hologic, Inc. recalls Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 0

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: E7058

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

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