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 20845357036807

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

What happened

Microbiologics Inc. is recalling 30 units of KWIK-STIK 2 Pack Klebsiella pneumoniae (Catalog# 01145P) distributed across twelve countries including the United States, Brazil, Canada, France, Germany, Japan, and the United Kingdom. The affected product was supposed to contain an NDM-1 positive bacterial strain but was confirmed to be NDM-1 negative instead, meaning the microorganism pellets in the recalled units do not have the intended antibiotic resistance characteristic.

The recalled lots are numbered 1145-06-1, 1145-06-2, 1145-06-3, 1145-06-4, 1145-06-6, and 1145-07-1. The source document does not specify what actions affected consumers should take in response to this recall.

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

Hazard

KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

Details from the source

Reason for recall: KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) 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: 30 units Lot/code info: Catalog 01145P, Lots 1145-06-1, 1145-06-2, 1145-06-3, 1145-06-4, 1145-06-6, 1145-07-1 UDI: UDI: 20845357036807

Source

Official record: FDA (Device enforcement) ↗

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

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