Z-1842-2015Class II

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

Name: Z-1842-2015 VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating...
Creator: Remel Inc
Published: 2015-05-19
License: https://open.fda.gov/license/

Remel Inc / initiated 2015-05-19 / Terminated

FDA source

Remel Inc began a recall of VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially... on 2015-05-19. FDA classified it as Class II and gives the reason as "Use of the recalled product may result in false positive reports". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1842-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-19
Posted: 2015-06-25
Terminated: 2017-03-24
Recalling firm: Remel Inc
Product: 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 code: MDB System, Blood Culturing
Reason for recall: Use of the recalled product may result in false positive reports.
FDA root cause: Release of Material/Component prior to receiving test results
Action: 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.
Quantity in commerce: 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, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
Product codes and lots: Serial numbers: 0169050501141020, 0169059801141031, 0169064701141210, 0169066801150105, 2200X1113, 2215X1113, 2236X1213, 2244X1213, 2272X0214, 2273X0214, 2274X0214, 2275X0214, 2298X0714, 2299X0714, 2300X0714, 2301X0714, 2303X0714, 2304X0714, 2326X0814, 2327X0814, and 2328X0814;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1842-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1841-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25
Z-1842-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25

Product code MDB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)