112 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Metasul LDH Head Rx Sterile
FDA Recall
Terminated
·Zimmer, Inc.·Product code KWA·September 4, 2012
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
FDA Recall
Open, Classified
·Beckman Coulter Ireland, Inc. Lismeehan O'Callaghan'S Mills Ireland·Product code KHS·October 14, 2025
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
Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier Laboratories LLC Spokane, WA 99207 USA . Labels on case states 25 STERILE EMPTY VIALS 10 mL/20mm Closure CAUTION: For manufacturing, Processing or Repacking Rx only NON-RETURNABLE LOT Hollister-Stier Laboratories LLC Spokane, WA 99207
FDA Recall
Terminated
·Hollister Stier Laboratories LLC·Product code LDH·April 20, 2006
AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine
FDA Recall
Terminated
·Medscience Inc·Product code LDH·March 22, 2016