MICROBIOLOGICS, INC.

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.

KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.

Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.

Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.

The RSV target may give a late Ct value and could potentially not pass QC.

The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.

Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.

Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.

The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.

The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control.

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.

Product not registered for use in the UK

Labeling error.

QC process was not adequate for the specification range.

The QC process was not adequate for the specification range.

Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.

Distributed product did not undergo proper release testing.

The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).

The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.

Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.

Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.

The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.

Contamination with S. epidermidis

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.

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.

Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.

The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.

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.

Potential contamination with S. epidermidis E. coli and S. warneri.

Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.

Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.

Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

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.

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.

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 impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.

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 buffer.

Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.

Product with incorrect shelf life.

Product with incorrect shelf life.

Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

Real-time shelf life testing failed at 24 months

Real-time shelf life testing failed at 24 months

Real-time shelf life testing failed at 24 months

Real-time shelf life testing failed at 24 months

Real-time shelf life testing failed at 24 months

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the quality control test causes a disruption for the testing laboratory which may result in repeated testing or the need for alternative test methods. This recall is applicable to the 8164 and 8165 sets only.

The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the quality control test causes a disruption for the testing laboratory which may result in repeated testing or the need for alternative test methods. This recall is applicable to the 8164 and 8165 sets only.

LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.

This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.

This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.

This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.

Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.

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 fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could pote

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 contaminate the patient area of the slide by flooding the control well with stain. This contamination could potentially lead to misdiagnosis and improper treatment of a patient.

Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris.