| 2025-05-06 |
Class II
|
Ongoing |
Z-2041-2025 |
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. … |
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Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae. |
| 2021-04-16 |
Class II
|
Terminated |
Z-1835-2021 |
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. |
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Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit. |
| 2020-12-21 |
Class II
|
Terminated |
Z-0919-2021 |
Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-2… |
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Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited. |
| 2020-10-23 |
Class II
|
Terminated |
Z-0655-2021 |
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is pr… |
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There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compro… |
| 2020-10-06 |
Class III
|
Terminated |
Z-0441-2021 |
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 |
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Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of… |