General Purpose Reagent

Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60

Neutralization Buffer may contain contaminants

1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP*

Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

Akkermansia Test

Distribution without premarket approval/clearance.

STA - Owren Koller. Model/Catalog Number: 00360

Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB

Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.

VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754.

VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.

Access Substrate, REF 81906, For use with the Access Immunoassay Systems

On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman Coulter has identified that Access Substrate bottles in the identified lots were released from manufacturing without labels. Missing label may cause some patient results reporting delay but will not cause any errorreous results. However, because labs are required to have redundancy such that delay would not significantly impact clinical management and because the defect is easily recognized by the user, the probability of harm is remote.

NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx S

Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results