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 70845357037335

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

What happened

Microbiologics Inc. is recalling KWIK-STIK 2 Pack units (Catalog# 5226P) used for quality control testing. The recalled product was supposed to contain a NDM-1 positive strain microorganism but was confirmed to be NDM-1 negative instead. The affected lots are 5226-03, 5226-04, 5226-05, 5226-06, and 5226-07, with a total of 5 units recalled.

The affected products were distributed to customers in the United States, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and the United Kingdom. The source document does not specify a remedy for consumers who have received this product.

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

Hazard

QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

Details from the source

Reason for recall: QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) 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: 5 units Lot/code info: Catalog 5226P, Lots 5226-03, 5226-04, 5226-05, 5226-06, 5226-07 UDI: 70845357037335

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• 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 refere2020-10-08
• 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 refere2020-10-08
• Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate.2020-10-08
• KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)2020-10-08
• Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FL2020-10-05

All FDA (Device enforcement) recalls