Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for th

FDA device recall Z-1033-2013 · posted 2013-04-01 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.

Action taken

Beckman Coulter sent an "Urgent Product Correction" letter dated February 12, 2013 via mail and email to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to place your Access system in the Ready or Not Ready mode. Lift the cover (as you do to access the probes) and look at the left side of the incubator unit under the peripump by the aspirate probe, if you see a silver pulley, immediately discontinue use and contact Technical Support also check for QC failures and system check failures; If you see a white pulley, this is the correct part and you can resume normal activity. Beckman will replace the metal pulley with the plastic pulley if you verified the your instrument has the silver pulley. The customers were also instructed to share this information with staff; and complete and return enclosed Response Form within 10 days. If you have any questions regarding this notice, please contact Technical support from the website: http://www.beckmancoulter.com or by phone at: 1-800-854-3633 in the United States and Canada.

Root cause

Device Design

Status

Terminated

Product code

JJE

Quantity affected

3500 units

Distribution

Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, L

Date initiated

2013-02-12

Date posted

2013-04-01

Date terminated

2013-12-23

Location

Brea, CA