DrugJun 20, 2018
Shadow Holdings DBA Bocchi Labs Acne Shave 3 Step Shaving System, contains one tube Acne recall — FDA D-0861-2018
CGMP Deviations: products may be contaminated with bacteria.
Class IIFDA: TerminatedShadow Holdings DBA Bocchi Labs
June 2018 recalls — page 8
These records include useful source details for the selected month.
DrugJun 20, 2018
Shadow Holdings DBA Bocchi Labs X-Jow (menthol USP) Pain Gel, 1.25% recall — FDA D-0858-2018
CGMP Deviations: products may be contaminated with bacteria.
Class IIFDA: TerminatedShadow Holdings DBA Bocchi Labs
DrugJun 20, 2018
RIJ Pharmaceutical Preferred Plus Pharmacy Antacid Extra Strength recall — FDA D-0842-2018
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class IIFDA: TerminatedRIJ Pharmaceutical LLC
DrugJun 20, 2018
RIJ Pharmaceutical Geritrex Senna Syrup (sennosides 8.8mg) recall — FDA D-0850-2018
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class IIFDA: TerminatedRIJ Pharmaceutical LLC
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes recall — FDA Z-2076-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience AIA-PACK TSH 3rd Generation recall — FDA Z-2077-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone recall — FDA Z-2092-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK Myoglobin recall — FDA Z-2072-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone recall — FDA Z-2084-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
GE Healthcare Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with recall — FDA Z-2102-2018
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
Class IIFDA: TerminatedGE Healthcare
Medical DeviceJun 13, 2018
Orthofix Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2118-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Ion Beam Applications S.A 12C (AdaPTinsight) Affected component: AdaPTinsight software recall — FDA Z-2109-2018
IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
Class IIFDA: TerminatedIon Beam Applications S.A.
Medical DeviceJun 13, 2018
Orthofix Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2122-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK C-Peptide II recall — FDA Z-2075-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker recall — FDA Z-2098-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate recall — FDA Z-2068-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Orthofix TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2133-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Orthofix Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2132-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Orthofix Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2125-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Orthofix Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2127-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK Estradiol recall — FDA Z-2088-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Orthofix H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2128-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK cTnI 2nd Gen recall — FDA Z-2073-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Siemens Healthcare Diagnostics ADVIA Centaur BNP recall — FDA Z-2053-2018
In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.