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Item #29608 Farmhouse White is recalled due to E. coli O103:H2.
Potential foreign material (plastic)
Failed stability specifications: Out of specification for hardness test
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303
Raw milk Whatcom Blue cheese is recalled due to E. coli O103:H2.
Raw milk Farmhouse cheeses are recalled due to E. coli O103:H2 and E. coli O74:H25.
Raw milk Mustard Seed cheese is recalled due to E. coli O103:H2 and E. coli O74:H25.
Raw milk Peppercorn cheese is recalled due to E.coli O26:H11
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).
Potential contamination of Salmonella Richmond
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.