|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
BIOPHEN UFH Control Plasma
|
3
|
09/15/2022
|
Aniara Diagnostica LLC
|
PTS Panels CHOL+GLU Test Strips (REF 1765)
|
3
|
09/14/2022
|
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
|
Helix Elite Inactivated Standard, labeled as:
a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF...
|
3
|
09/14/2022
|
Microbiologics Inc
|
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have...
|
3
|
09/10/2022
|
Steris Corporation Hopkins Facility
|
AXIOM Sensis or Sensis Vibe Combo systems as follows:
System Material...
|
3
|
08/18/2022
|
Siemens Medical Solutions USA, Inc
|
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
|
3
|
07/25/2022
|
Zeiss, Carl Inc
|
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
|
3
|
07/20/2022
|
Randox Laboratories Ltd.
|
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
|
3
|
07/20/2022
|
Randox Laboratories Ltd.
|
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers:
Part # Part Name
...
|
3
|
07/18/2022
|
Synapse Biomedical Inc
|
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determin...
|
3
|
07/15/2022
|
R & D Systems, Inc.
|