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EliA GBM Wells, Material Number 14551401, for Phadia 250,... (Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden) – complaints that specific samples prod... (2023)

Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.

High

FDAMay 24, 2023Nationwide• Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden

RET Distal Probe. Used in Fluorescence in situ hybridizat... (Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom) – dnas used during the manufacture of t... (2023)

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

Low

FDAMay 24, 2023Nationwide

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EliA GBM Wells, Material Number 14551401, for Phadia 250,... (Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden) – complaints that specific samples prod... (2023)

RET Distal Probe. Used in Fluorescence in situ hybridizat... (Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom) – dnas used during the manufacture of t... (2023)

RET Proximal Probe. Used in Fluorescence in situ hybridiz... (Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom) – dnas used during the manufacture of t... (2023)

Power-PRO 2- A powered ambulance cot that consists of a p... (Stryker Medical Division of Stryker Corporation) – base leg assembly may bend and result... (2023)

NeuMoDx Cartridge-used for extraction, purification, ampl... (NeuMoDx Molecular Inc) – top label on some of the neumodx cart... (2023)

SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, ... (MEDLINE INDUSTRIES, LP Northfield) – the kits incorrectly contain circlamp... (2023)

PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x1... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruct... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; ... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Revize; Collagen Matrix for Soft Tissue Reconstruction; R... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

SurgiMend; Collagen Matrix for Soft Tissue Reconstruction... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Rec... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-6... (Young Dental Manufacturing I, LLC) – the iris 5% fluoride varnish white mi... (2023)

PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Siz... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

wDR 2.2 Mobile Digital Diagnostic X-Ray System (SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain) – there is a software login in issue th... (2023)