AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0 is a microparticle enzyme immuno

FDA device recall Z-1048-2009 · posted 2009-04-15 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

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

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.

Root cause

Employee error

Status

Terminated

Product code

LOM

Quantity affected

967 kits

Distribution

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

Date initiated

2009-01-19

Date posted

2009-04-15

Date terminated

2010-09-11

Location

Abbott Park, IL