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FDA (Device enforcement)Recalled 2020-10-08closedclass ii

Microbiologics Inc: Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contain

Is my product affected?

Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the refere

  • UPC 30845357036811

Check against the official notice below — it lists the full affected range.

What happened

Microbiologics Inc. is recalling one unit of KWIK-STIK 6 Pack Klebsiella pneumoniae (Catalog# 01145K, Lot 1145-06-5) that was distributed to multiple countries including the United States, Brazil, Canada, and several European nations. The product was supposed to contain an NDM-1 positive bacterial strain but testing confirmed it was NDM-1 negative instead, meaning it does not contain the intended antibiotic-resistant microorganism for which it was labeled.

The KWIK-STIK is a microbiological testing device that consists of a lyophilized microorganism pellet, hydrating fluid, and inoculating swab sealed in a laminated pouch. The recall notice does not specify what actions affected consumers should take regarding this recalled unit.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

Details from the source

Reason for recall: KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative. Distribution: Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom. Quantity: 1 unit Lot/code info: Catalog 01145K, Lot 1145-06-5 UDI: 30845357036811

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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