Remel VersaTREK Instrument Series 240 Recalled for False Positive Reports
Remel Inc. is recalling 143 VersaTREK Instrument Series 240 devices because their use may result in false positive reports. The devices are used to cultivate microorganisms from blood and other sterile bodily fluids.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves false positive reports from a diagnostic device, which poses a risk of harm through incorrect medical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Remel Inc. is recalling 143 units of the VersaTREK Instrument Series 240 (REF 6240). The VersaTREK System is a medical device used for cultivating and recovering microorganisms, specifically bacteria and yeasts, from blood and other normally sterile bodily fluids.
The recall was initiated because the use of the recalled product may result in false positive reports. This hazard could lead to incorrect diagnostic results for patients.
The affected devices were distributed worldwide, including to specific states in the United States and numerous international countries. Consumers and healthcare facilities should check their inventory for the specific serial numbers listed in the official recall notice and stop using the affected devices.
The recalled product
- Product
- VersaTREK Instrument Series 240 REF 6240, 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.
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 143
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers: 0169039201140624
- 0169040501140626
- 0169050101141007
- 0169068601141216
- 0169078101150213
- 2163X1013
- 2164X1013
- 2165X1013
- 2166X1013
- 2167X1013
- 2168X1013
- 2169X1013
- 2170X1013
- 2171X1013
- 2172X1013
- 2173X1013
- 2174X1013
- 2175X1013
- 2176X1013
- 2177X1013
Distribution
Part of a larger recall action
This product is one of 2 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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