Remel Inc: Medical Device Recall in 2015 - (Recall #: Z-1842-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.

Product Classification:

Class II

Date Initiated: May 19, 2015

Date Posted: July 1, 2015

Recall Number: Z-1842-2015

Event ID: 71291

Reason for Recall:

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

Status: Terminated

Product Quantity: 21 devices

Code Information:

Serial numbers: 0169050501141020, 0169059801141031, 0169064701141210, 0169066801150105, 2200X1113, 2215X1113, 2236X1213, 2244X1213, 2272X0214, 2273X0214, 2274X0214, 2275X0214, 2298X0714, 2299X0714, 2300X0714, 2301X0714, 2303X0714, 2304X0714, 2326X0814, 2327X0814, and 2328X0814;

Distribution Pattern:

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, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated