KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Catalog Number HL163263 OEM Private Label with Healthlink; UDI: N/A (OEM agreement with Healthlink ended in Q1 2016 before UDI was required for class 1 IVDs) Lot Number (Expiration Date): 959-74-1 (10/08/2014), 959-75-2 (04/22/2015), 959-75-3 (04/22/2015), 959-75-6 (04/22/2015), 959-75-7 (04/22/2015), 959-75-10 (04/22/2015), and 959-76-2 (07/08/2015)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Microbiologics Inc
Reason for Recall:
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299

Product Codes/Lot Numbers:

Catalog Number HL163263 OEM Private Label with Healthlink; UDI: N/A (OEM agreement with Healthlink ended in Q1 2016 before UDI was required for class 1 IVDs) Lot Number (Expiration Date): 959-74-1 (10/08/2014), 959-75-2 (04/22/2015), 959-75-3 (04/22/2015), 959-75-6 (04/22/2015), 959-75-7 (04/22/2015), 959-75-10 (04/22/2015), and 959-76-2 (07/08/2015)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0714-2022

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