Microbiologics recalls

Microbiologics appears in 66 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance…
  FDA Device · Class II · 2021-09-29 · Microbiologics
  Reason: The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
• SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performan…
  FDA Device · Class II · 2021-09-29 · Microbiologics
  Reason: The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
• Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of…
  FDA Device · Class II · 2020-11-11 · Microbiologics
  Reason: Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
• Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab
  FDA Device · Class II · 2020-11-04 · Microbiologics
  Reason: 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.
• Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab
  FDA Device · Class II · 2020-11-04 · Microbiologics
  Reason: 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.
• Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab
  FDA Device · Class II · 2020-11-04 · Microbiologics
  Reason: 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.
• KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
  FDA Device · Class II · 2020-04-15 · Microbiologics
  Reason: KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.
• Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)7084535…
  FDA Device · Class II · 2020-04-15 · Microbiologics
  Reason: KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.
• Vaginal Verification Panel Ref 8208 Lot 8208-11
  FDA Device · Class II · 2020-02-12 · Microbiologics
  Reason: Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no…
• Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to e…
  FDA Device · Class II · 2020-01-22 · Microbiologics
  Reason: The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate b…
• Cepheid Xpert C. difficile/Epi Control Panel
  FDA Device · Class III · 2019-06-26 · Microbiologics
  Reason: Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
• Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTI…
  FDA Device · Class II · 2019-06-12 · Microbiologics
  Reason: Product with incorrect shelf life.
• Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION R…
  FDA Device · Class II · 2019-06-12 · Microbiologics
  Reason: Product with incorrect shelf life.
• Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
  FDA Device · Class II · 2019-03-13 · Microbiologics
  Reason: Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.
• Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides)
  FDA Device · Class II · 2013-04-03 · Microbiologics
  Reason: Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10. These products are being recalled because the control organisms are not properly…
• Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe,…
  FDA Device · Class II · 2012-07-11 · Microbiologics
  Reason: Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram negative control organism (E.coli) is not properly fixated on the slide, which may cause the user to unintentionally contamina…