Recall Z-0981-2010
Calbiotech Inc · initiated August 27, 2008
Product
ANA IgG ELISA 96 Well Kit, Catalog Number: AN033G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
Codes / lots: Lot Number: ANG2472, ANG2601, and ANG268
Reason for recall
The recall was initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. The firm reported although there is no potential health hazard related to this recall, the recall was initiated because Calbiotech is fully committed to compliance with all State and Federal regulations.
FDA-determined cause: Labeling False and Misleading
Action taken
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
Details
- Recall number
- Z-0981-2010
- Initiated
- August 27, 2008
- Posted by FDA
- March 5, 2010
- Terminated
- March 5, 2010
- Product code
- LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- Quantity
- 21 Kits
- Distribution
- FL, and VA
- Recalling firm
- Calbiotech Inc, Spring Valley, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0982-2010 | Brucella IgG ELISA 96 Well Kit, Catalog Number: BA052G The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0983-2010 | Brucella IgM ELISA 96 Well Kit, Catalog Number: BA053M The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0984-2010 | Cardiolipin IgM ELISA 96 Well Kit, Catalog Number: CA036M The products in question are…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0985-2010 | Chlamydia Pneumoniae IgG ELISA 96 Well Kit, Catalog Number: CP083G The products in…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0986-2010 | Chlamydia Pneumoniae IgM ELISA 96 Well Kit, Catalog Number: CP095M The products in…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0987-2010 | Chlamydia Trachomatis IgG ELISA 96 Well Kit, Catalog Number: CT054G The products in…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0988-2010 | Chlamydia Trachomatis IgM ELISA 96 Well Kit, Catalog Number: CT055M The products in…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0989-2010 | Chlamydia Trachomatis IgA ELISA 96 Well Kit, Catalog Number: CT056A The products in…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0990-2010 | dsDNA IgG ELISA 96 Well Kit, Catalog Number: DD037G The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0991-2010 | Dengue IgG ELISA 96 Well Kit, Catalog Number: DE050G The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0992-2010 | Dengue IgM ELISA 96 Well Kit, Catalog Number: DE051M The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0993-2010 | EBV VCA IgG ELISA 96 Well Kit, Catalog Number: EV010G The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0994-2010 | EBV VCA IgM ELISA 96 Well Kit, Catalog Number: EV012M The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0995-2010 | H. Pylori IgA ELISA 96 Well Kit, Catalog Number: HP014A The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0996-2010 | H. Pylori IgM ELISA 96 Well Kit, Catalog Number: HP015M The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0997-2010 | Mycoplasma IgG ELISA 96 Well Kit, Catalog Number: MP020G, The products in question are…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0998-2010 | Mycoplasma IgM ELISA 96 Well Kit, Catalog Number: MP021M The products in question are…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-0999-2010 | Mumps IgM ELISA 96 Well Kit, Catalog Number: MP060G The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-1000-2010 | Measles IgG ELISA 96 Well Kit, Catalog Number: MS018G The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-1001-2010 | Measles IgM ELISA 96 Well Kit, Catalog Number: MS019M The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-1002-2012 | Toxoplasma IgM ELISA 96 Well Kit, Catalog Number: TX055M The products in question are…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-1003-2010 | VZV IgG ELISA 96 Well Kit, Catalog Number: VZ081G The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |
| Z-1004-2010 | VZV IgM ELISA 96 Well Kit, Catalog Number: VZ082M The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | 08/27/2008Terminated |