VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recove

FDA device recall Z-1842-2015 · posted 2015-06-25 · Terminated

Recall details

Recalling firm

Remel Inc

Reason for recall

Use of the recalled product may result in false positive reports.

Action taken

Remel, Inc. a part of Thermo Scientific sent a Product Correction Notification dated May 19, 2015, to all affected customers. The notification states the problem with the device and that the recalling firm's Technical Services department will be contacting the customer to schedule a field service of the device to correct the issue. Customers were instructed to notify any personnel who need to be notified of the potential for a false positive resulting from rare inconsistent barometric pressure readings. Return the attached Medical Device Recall Return Response form acknowledging receipt of the notice of the affected product. If product was further distributed customers were instructed to contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact the Technical Services Department at 800-642-7029. For questions regarding this recall call 770-409-0713.

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

MDB

Quantity affected

21 devices

Distribution

Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indones

Date initiated

2015-05-19

Date posted

2015-06-25

Date terminated

2017-03-24

Location

Lenexa, KS