UltraVision Detection System; Anti-Rabbit, Alk-Phos/BCIP/NBT (Ready to Use) Manufactured by: Lab Vision Corporation 4636

FDA device recall Z-1088-2012 · posted 2012-02-22 · Terminated

Recall details

Recalling firm

Lab Vision Corporation

Reason for recall

Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.

Action taken

Lab Vision Corporation of Thermo Fisher Scientific sent a Product Recall Notification letters dated January 11, 2012 to all affected customers. The letter identified the affected products, reason for recall and necessary actions to be taken. Customers were instructed to examine inventory, discontinue use, destroy any remaining inventory, follow normal procedure to order an alternate lot of the affected products, retain a copy of this letter for their laboratory records, if the affected products were further distributed provide a copy of this letter to them and complete the attached Customer Recall Response Form and return within 5 days. For questions regarding this information, U.S. customers should call Technical Support at 510-771-1595. Customers outside the U.S. should contact their local area Customer Service.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NJT

Quantity affected

31 kits in total

Distribution

Worldwide Distribution - USA (nationwide) FL, IL, MA, TX and countries of Denmark, Turkey, Italy, Poland, Canada, Japan, Germany, Egypt and Greece.

Date initiated

2012-01-11

Date posted

2012-02-22

Date terminated

2012-07-20

Location

Fremont, CA