—#77459

Product

AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0 is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of total antibodies (IgG and IgM) to hepatitis B virus core antigen (anti-HBc) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes containing lithium heparin); list 8B88-20

FDA product code: LOM — Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Device class: Class 2
Medical specialty: Microbiology
PMA numbers: P060012S001
Affected lot / code info: lot 66253M200

Why it was recalled

Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: Worldwide Distribution -- USA including Puerto Rico and countries of Germany, Mexico, Hong Kong, and Japan.

Timeline

Recall initiated: 2009-01-19
Posted by FDA: 2009-04-15
Terminated: 2010-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #77459. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.