Recall Z-1050-2009
Abbott Laboratories · initiated January 19, 2009
Product
AxSYM Myoglobin Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System; list 3E43-20
Codes / lots: lot 63493M200
Reason for recall
Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
FDA-determined cause: Employee error
Action taken
Consignees were sent a Product Correction-Immediate Action Required letter on 1/19/09. The letter informed users of the reported increased frequency of probe crashes when using the affected reagent pack lots and provided instructions on what actions the laboratory can take if they have a defective reagent pack or experience a probe crash with their system. Users need to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading reagent pack on instrument; and discard any reagent packs that do not open properly. If a probe crash is observed prior to testing samples again, a probe crash recovery must be performed following the procedure in the Operations Manual. A copy of the communication needs to be provided to any laboratory that you may have forwarded affected lots to. Users were requested to return a customer reply letter acknowledging receipt and understanding of the letter. For additional information, contact Abbott Labs at 1-877-4ABBOTT.
Details
- Recall number
- Z-1050-2009
- Initiated
- January 19, 2009
- Posted by FDA
- April 15, 2009
- Terminated
- September 11, 2010
- Product code
- DDR – Myoglobin, Antigen, Antiserum, Control
- Quantity
- 822 kits
- Distribution
- Worldwide Distribution -- USA including Puerto Rico and countries of Germany, Mexico, Hong Kong, and Japan.
- Recalling firm
- Abbott Laboratories, Abbott Park, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1046-2009 | AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | 01/19/2009Terminated |
| Z-1047-2009 | AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | 01/19/2009Terminated |
| Z-1048-2009 | AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | 01/19/2009Terminated |
| Z-1049-2009 | AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM Folate is…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | 01/19/2009Terminated |
| Z-1051-2009 | AxSYM Troponin-I ADV Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | 01/19/2009Terminated |