Hardy Diagnostics — Federal Records

FDA Recall: Hardy Diagnostics — Class II 20210203

Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited. | Product: Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G...

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FDA Device Recall: Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. 2021-06-16

Class II — Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.

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FDA Device Recall: Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Man 2021-02-03

Class II — Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.

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FDA Device Recall: Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/ 2020-12-30

Class II — There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-1...

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FDA Device Recall: Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 2020-11-18

Class III — Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date...

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FDA Recall: Hardy Diagnostics — Class II 20160720

Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient. | Product: QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80....

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FDA Device Recall: QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematica 2016-07-20

Class II — Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.

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FDA Device Recall: Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detect 2016-05-04

Class II — Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterio...

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FDA Recall: Hardy Diagnostics — Class II 20150805

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azid | Product: Hardy Diagnostics VRE Broth, 5ml c...

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FDA Device Recall: FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fast 2015-12-30

Class II — The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.

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FDA Device Recall: HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Ty 2015-09-02

Class II — Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the ident...

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FDA Device Recall: Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 2015-08-05