medical MODERATE Updated 2022-03-16

Remel Inc recalls Thermo Scientific Sensititre Gram Negative Susceptibility Te

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Recalled Product

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

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Hazard / Issue

There are lower than expected MICs for some gram negative species.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16)

✅ 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.
View official government recall