The Recall Desk
HighFDA (Devices)·Z-0714-2022·Announced 2022-03-09

Quality Control Kit Bacterial Strain Shows Unexpected Gentamicin Susceptibility

Microbiologics has recalled KWIK-STIK quality control kits due to a specific lot failing to meet resistance specifications for Gentamicin Synergy. The affected bacterial strain showed unexpected susceptibility when it should have been resistant.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with no reported illnesses or injuries, but a quality control failure that could compromise laboratory testing accuracy if defective strains are used to validate culture media. Per the rubric, theoretical risk-of-harm products with no reported injuries score at most High (3).

Plain-English summary

Microbiologics Inc is recalling KWIK-STIK quality control kits (catalog HL163263) containing Enterococcus faecalis bacterial strains used to validate culture media. Affected lot numbers include 959-74-1 (exp. 10/08/2014), 959-75-2, 959-75-3, 959-75-6, 959-75-7, and 959-75-10 (exp. 04/22/2015), and 959-76-2 (exp. 07/08/2015).

During in-house testing, a specific lot was found susceptible to Gentamicin Synergy, contrary to product specifications. These kits are designed to be resistant to high levels of Gentamicin and resistant to Gentamicin Synergy. The defect means the quality control strain did not meet required specifications for proper validation of culture media.

The affected kits were distributed worldwide, including throughout the United States and to Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, South Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, United Arab Emirates, and Vietnam.

Laboratories that received affected lots should be aware of the quality control failure and take appropriate measures to ensure accurate culture media validation.

The recalled product

Product
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
Manufacturer
Microbiologics Inc
Category
Medical Device — Laboratory Reagent
Hazard
  • antibiotic-susceptibility-error
  • quality-control-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Catalog Number HL163263 OEM Private Label with Healthlink
  • 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)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category