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    Metasul LDH Head Rx Sterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KWA·September 4, 2012

    MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30

    FDA Recall
    Terminated ·Sentinel CH SpA Via Robert Koch·Product code NDW·June 28, 2019

    Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320

    FDA Recall
    Terminated ·Sentinel CH SpA Via Robert Koch·Product code NDW·June 28, 2019

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 60/54, code T, Zimmer, Winterthur, Switzerland; REF 01.00214.160. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R, Zimmer, Winterthur, Switzerland; REF 01.00214.158. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 66/60, code Z, Zimmer, Winterthur, Switzerland; REF 01.00214.166. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 48/42, code H, Zimmer, Winterthur, Switzerland; REF 01.00214.148. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 52/46, code L, Zimmer, Winterthur, Switzerland; REF 01.00214.152. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 50/44, code J, Zimmer, Winterthur, Switzerland; REF 01.00214.150. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 46/40, code F, Zimmer, Winterthur, Switzerland; REF 01.00214.146. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 64/58, code X, Zimmer, Winterthur, Switzerland; REF 01.00214.164. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 56/50, code P, Zimmer, Winterthur, Switzerland; REF 01.00214.156. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 54/48, code N, Zimmer, Winterthur, Switzerland; REF 01.00214.154. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 44/38, code D, Zimmer, Winterthur, Switzerland; REF 01.00214.144. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 62/56, code V, Zimmer, Winterthur, Switzerland; REF 01.00214.162. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIX·January 6, 2014

    Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CFJ·August 11, 2020

    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.

    FDA Recall
    Terminated ·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code GWQ·November 11, 2015

    VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIG·June 12, 2013

    VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIP·June 12, 2013