FDA Device recall Z-1842-2015
VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc
- FDA Device
- Class II
- terminated
- Published 2015-07-01
On 2015-07-01 the FDA classified a Class II recall of VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc by Remel, citing use of the recalled product may result in false positive reports.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1842-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-19 |
| Published | 2015-07-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Remel |
| Distribution | US |
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.
Reason
Use of the recalled product may result in false positive reports.
Identifiers
| code_info | Serial numbers: 0169050501141020, 0169059801141031, 0169064701141210, 0169066801150105, 2200X1113, 2215X1113, 2236X1213…Serial numbers: 0169050501141020, 0169059801141031, 0169064701141210, 0169066801150105, 2200X1113, 2215X1113, 2236X1213, 2244X1213, 2272X0214, 2273X0214, 2274X0214, 2275X0214, 2298X0714, 2299X0714, 2300X0714, 2301X0714, 2303X0714, 2304X0714, 2326X0814, 2327X0814, and 2328X0814; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1842-2015%22
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